Updated: 8th September 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
What Is Medical Device Validation?
Medical device validation is the documented process of demonstrating, through objective evidence, that a device, process or system is capable of consistently fulfilling its specified requirements and intended purpose.
Validation is a fundamental part of medical device development and manufacturing. However, the term “validation” covers several different activities, and it is important to distinguish validation from verification.
A useful way of understanding the difference is:
Verification asks: “Did we design or produce it according to the specified requirements?”
Validation asks: “Does the resulting device or process achieve its intended purpose under the conditions in which it will be used?”
ISO 13485 reflects this distinction by establishing separate requirements for design and development verification, design and development validation, and validation of production and service provision processes
Design Verification
Design verification confirms that design outputs meet the corresponding design input requirements.
For example, if a design input specifies that a medical device must withstand a particular mechanical load, verification may involve testing the finished design against a predefined acceptance criterion.
Verification activities may include:
- Inspection and measurement
- Bench testing
- Engineering analysis and calculations
- Electrical safety and EMC testing
- Software verification
- Mechanical testing
- Comparison of design outputs against specifications
- Review of drawings and technical documentation
Verification should be planned, documented and traceable back to the applicable design inputs.
Design Validation
Design validation demonstrates that the resulting medical device is capable of meeting the requirements for its specified application or intended use.
ISO 13485 requires design validation to be performed according to planned and documented arrangements and using representative product, with the rationale for the selected product documented.
Depending on the device, design validation may involve activities such as:
- Simulated-use testing
- Usability validation
- Validation under expected environmental and operating conditions
- Clinical evaluation
- Clinical investigation, where required
- Performance evaluation for IVDs
- Validation of device interfaces and interactions with other products
Design validation therefore focuses on whether the finished device meets user needs and performs appropriately for its intended purpose.
Process Validation
Process validation is different from design validation.
Manufacturing and service processes require validation where the resulting output cannot be fully verified by subsequent monitoring or measurement and deficiencies may only become apparent after the product is in use.
Depending on the medical device and manufacturing process, this can include:
- Sterilisation processes
- Packaging and sealing processes
- Cleaning processes
- Welding and bonding
- Moulding
- Coating processes
- Automated manufacturing processes
- Software used in production or the quality management system, where applicable
Process validation provides documented evidence that a process can operate within established parameters and consistently produce an output meeting predetermined requirements.
Validation Is a Lifecycle Activity
Validation should not be treated as a single exercise performed immediately before a medical device is placed on the market.
Verification and validation activities begin during design and development and continue through design transfer, manufacturing and subsequent changes to the device or its production processes. ISO 13485 also requires design and development changes to be reviewed, verified and validated as appropriate before implementation.
Post-market information, corrective actions, design changes, manufacturing changes, new suppliers or changes to validated processes may therefore trigger a need to review existing validation evidence or perform revalidation.
A well-designed validation strategy brings these activities together within the manufacturer’s quality management system and risk management process, ensuring that the level of validation is appropriate to the device, process and associated risks.
Why Is Medical Device Validation Required?
Verification and validation provide the objective evidence manufacturers need to demonstrate that a medical device has been appropriately designed, manufactured and controlled throughout its lifecycle.
The extent of validation required will depend on the device, its intended purpose, associated risks, manufacturing processes and the regulatory markets in which it will be placed.
EU MDR Requirements
Under Regulation (EU) 2017/745 (EU MDR), manufacturers must demonstrate that their devices conform with the applicable General Safety and Performance Requirements (GSPRs) in Annex I.
The EU MDR requires devices to achieve the performance intended by the manufacturer and to be designed and manufactured so that they are safe, effective and suitable for their intended purpose. Manufacturers must also establish and maintain systems for risk management and quality management.
Importantly, Annex II of the EU MDR specifically requires the technical documentation to contain:
“Product verification and validation”
This section of the technical documentation must contain the results and critical analyses of the verification and validation tests and studies undertaken to demonstrate conformity with the applicable requirements.
Depending on the device, this evidence may include:
- Engineering and laboratory testing
- Simulated-use testing
- Biocompatibility and biological evaluation
- Physical, chemical and microbiological characterisation
- Electrical safety and electromagnetic compatibility (EMC)
- Software verification and validation
- Stability and shelf-life testing
- Packaging validation
- Sterilisation validation
- Performance and safety testing
- Clinical evidence
The precise combination of verification and validation activities therefore needs to be determined for each device rather than applying a standard testing checklist to every product.
Need an Introduction to the EU Medical Device Regulation?
Verification and validation form an important part of demonstrating conformity with the EU MDR. If you're looking for a broader overview of device classification, GSPRs, technical documentation, clinical evaluation, conformity assessment, CE marking and post-market requirements, read our Complete Guide to the EU Medical Device Regulation.
UK MDR Requirements
Medical devices placed on the Great Britain market must comply with the applicable requirements of the UK Medical Devices Regulations 2002 (UK MDR 2002), as amended.
Manufacturers need appropriate evidence demonstrating that their devices satisfy the applicable Essential Requirements and the relevant conformity assessment requirements.
Designated standards can be used to help demonstrate conformity with the corresponding Essential Requirements. The MHRA identifies standards including ISO 13485 for quality management and ISO 14971 for risk management, alongside process-specific standards such as those relating to sterilisation.
Use of designated standards is generally voluntary, but where a manufacturer chooses another approach, it must still be able to demonstrate that the applicable regulatory requirements have been satisfied.
Need an Introduction to UK Medical Device Regulations?
Medical device verification and validation also support compliance with the requirements applying in Great Britain. If you're looking for a broader overview of the UK MDR, UKCA marking, MHRA registration, UK Responsible Person requirements, conformity assessment and post-market compliance, read our Complete Guide to UK Medical Device Regulations.
ISO 13485 and Validation
ISO 13485 provides the internationally recognised quality management system framework used by medical device manufacturers and establishes requirements affecting validation throughout the product lifecycle.
Within an ISO 13485 quality management system, manufacturers need to consider areas including:
- Design and development verification
- Design and development validation
- Validation of production and service provision processes
- Validation of sterilisation and sterile barrier system processes, where applicable
- Validation of software used within production and the quality management system
- Control of changes that could affect validated processes
- Revalidation where necessary
This means validation should not operate as an isolated regulatory exercise. It should form part of the manufacturer’s overall quality management system and be connected to design controls, risk management, production controls and change management.
Need an Introduction to ISO 13485?
Verification and validation activities should be controlled within the manufacturer's Quality Management System. If you're looking for a broader overview of design controls, process validation, risk management, documentation, CAPA and other medical device QMS requirements, read our Complete Guide to ISO 13485.
A Risk-Based Approach to Validation
Not every medical device requires the same level or type of validation.
Manufacturers should determine the appropriate verification and validation activities based on factors such as:
- Intended purpose
- Device classification
- Patient and user risks
- Design complexity
- Materials and patient contact
- Manufacturing processes
- Sterility requirements
- Software functionality
- Packaging and shelf life
- Reprocessing requirements
- Applicable regulatory requirements and standards
Risk management should therefore help determine what needs to be verified or validated, how extensively it should be assessed and what acceptance criteria are appropriate.
The resulting evidence becomes an important part of the medical device technical documentation and supports the manufacturer’s demonstration that the device meets the applicable safety and performance requirements. Under the EU MDR, verification and validation evidence is expressly part of the Annex II technical documentation.
Need an Introduction to ISO 14971 Risk Management?
Risk management should help determine what needs to be verified or validated and the level of evidence required. If you're looking for a broader overview of hazard identification, risk analysis, risk evaluation, risk controls, residual risk and lifecycle monitoring, read our Complete Guide to ISO 14971 Risk Management.
Types of Medical Device Validation
There is no single validation programme that applies to every medical device. The verification and validation activities required depend on the device design, intended purpose, manufacturing processes, materials, sterility, packaging, software, reprocessing requirements and associated risks.
Manufacturers should therefore establish a validation strategy that identifies the activities applicable to their particular device and defines how objective evidence will be generated and documented.
Some of the most common areas include the following.
Design Verification and Validation
Design verification and design validation are fundamental elements of medical device design control.
Design verification demonstrates that the design outputs meet the established design input requirements. This may involve engineering analysis, inspection, measurement, bench testing, software testing or other objective methods.
Design validation considers whether the finished device meets user needs and its intended use when used under defined or simulated-use conditions.
The two activities are related but answer different questions:
| Activity | Key Question | Typical Evidence |
|---|---|---|
| Design verification | Did we design the device correctly against its specifications? | Bench tests, measurements, engineering analysis, software testing and inspection |
| Design validation | Did we design the right device for its intended use and users? | Simulated-use studies, usability validation, performance testing and other validation evidence |
Both should be planned during development, with predefined methods and acceptance criteria.
Process Validation
Some manufacturing processes produce outputs that cannot be fully verified through subsequent inspection or testing. In these circumstances, the process itself must be appropriately validated.
Examples can include:
- Welding and bonding
- Heat sealing
- Moulding
- Coating
- Automated manufacturing operations
- Aseptic processes
- Cleaning processes
- Sterilisation processes
A process validation programme will commonly consider equipment, process parameters, operating limits, acceptance criteria, personnel, monitoring and the evidence required to demonstrate consistent process performance.
Where appropriate, validation may include:
Installation Qualification (IQ) – confirming that equipment and systems have been installed correctly and according to defined specifications.
Operational Qualification (OQ) – demonstrating that the process or equipment operates as intended throughout established operating ranges.
Performance Qualification (PQ) – demonstrating that the process consistently produces acceptable results under routine production conditions.
IQ, OQ and PQ should be applied where appropriate rather than assumed to be mandatory terminology for every validation activity.
Cleaning Validation
Cleaning validation demonstrates that a defined cleaning process consistently reduces contaminants to predetermined acceptable levels.
This may be relevant to manufacturing processes and particularly important for reusable medical devices that are intended to be cleaned and reprocessed between uses.
Depending on the device, validation may need to consider:
- Residual manufacturing contaminants
- Organic and inorganic residues
- Cleaning agents and detergent residues
- Microbiological contamination
- Device geometry and difficult-to-clean areas
- Worst-case devices or configurations
- Cleaning parameters
- Repeated processing cycles
- Compatibility of cleaning with device materials and performance
For reusable devices, the manufacturer’s validated processing instructions must also provide users with appropriate information for safe and effective reprocessing.
Need More Guidance on Medical Device Cleaning Validation?
Cleaning processes must be appropriately validated where cleanliness is critical to device safety, performance or successful reprocessing. Learn more about validation methods, acceptance criteria, worst-case conditions and documenting cleaning effectiveness in our Complete Guide to Medical Device Cleaning Validation.
Sterilisation Validation
For devices supplied sterile, manufacturers must demonstrate that the selected sterilisation process is appropriate for the product and capable of consistently achieving the required level of sterility.
The applicable validation approach depends on the sterilisation method used.
Common methods include:
- Ethylene oxide sterilisation
- Radiation sterilisation
- Moist heat sterilisation
- Other validated sterilisation technologies where appropriate
Sterilisation validation must be considered together with product design, materials, bioburden, packaging, manufacturing processes and the maintenance of sterility throughout the claimed shelf life.
Sterilisation is a process where the effectiveness cannot normally be fully verified by inspection of every finished product. Robust process validation and ongoing process control are therefore essential.
Need More Guidance on Medical Device Sterilisation?
Sterilisation processes must be appropriately validated to demonstrate that medical devices can consistently achieve the required sterility assurance while maintaining their safety and performance. Learn more about sterilisation methods, process validation, applicable standards and regulatory requirements in our Complete Guide to Medical Device Sterilisation.
Packaging Validation
Medical device packaging performs an important safety function, particularly where the packaging forms a sterile barrier system.
Packaging validation may need to demonstrate that the packaging system can:
- Maintain product integrity
- Protect the device during handling and distribution
- Maintain sterile barrier integrity where applicable
- Withstand the intended sterilisation process
- Remain suitable throughout the claimed shelf life
- Allow appropriate aseptic presentation where required
Validation can therefore involve package seal validation, integrity testing, accelerated and real-time ageing, transportation or distribution simulation and evaluation following sterilisation.
For terminally sterilised medical devices, ISO 11607-1 and ISO 11607-2 provide the principal framework for packaging systems and validation of forming, sealing and assembly processes.
Need More Guidance on Medical Device Packaging Validation?
Medical device packaging must protect the device throughout handling, distribution and storage and, where applicable, maintain sterile barrier integrity throughout its claimed shelf life. Learn more about ISO 11607, seal validation, packaging integrity, ageing studies and distribution testing in our Complete Guide to Medical Device Packaging Validation.
Software Validation
Software can require verification and validation both when it forms part of the medical device and when software is used to support manufacturing or the quality management system.
For medical device software, activities should be proportionate to the software’s intended purpose, complexity and associated risks and may include:
- Requirements verification
- Architecture and design verification
- Unit and integration testing
- System testing
- Software risk control verification
- Interface testing
- Usability-related validation
- Validation in the intended use environment
Software used in production or within the quality management system must also be validated where required before initial use and, as appropriate, following changes.
Developing Medical Device Software?
Medical device software requires a structured lifecycle approach to development, verification, testing, risk management and maintenance. Learn how IEC 62304 applies to medical device software and Software as a Medical Device (SaMD) in our Complete Guide to IEC 62304 and Medical Device Software Development.
Electrical Safety and EMC Testing
For electrically powered medical devices, electrical safety and electromagnetic compatibility testing can form an important part of the overall verification and validation evidence.
The IEC 60601 family of standards is particularly important for medical electrical equipment.
Testing may address areas including:
- Protection against electrical shock
- Mechanical hazards
- Excessive temperatures
- Essential performance
- Electromagnetic emissions
- Electromagnetic immunity
- Environmental and operating conditions
It is important, however, to distinguish this from process validation. Electrical safety and EMC testing are primarily product verification activities used to demonstrate that the device satisfies defined safety and performance requirements.
Need More Guidance on Medical Device Electrical Safety?
Medical electrical equipment must be appropriately evaluated for electrical safety, essential performance and electromagnetic compatibility. Learn more about IEC 60601, electrical safety testing, EMC requirements and the evidence needed to support regulatory compliance in our Complete Guide to Electrical Safety in Medical Devices.
How to Develop a Medical Device Validation Plan
Medical device verification and validation should be planned rather than performed as a collection of unrelated tests at the end of product development.
A validation plan provides a structured framework for identifying what needs to be verified or validated, why the activity is required, how it will be performed and what evidence will demonstrate successful completion.
The scope of the plan should be proportionate to the complexity and risk of the device and its associated manufacturing processes.
Step 1: Define the Device and Intended Purpose
Begin with a clear understanding of the medical device, its intended purpose and the conditions under which it will be manufactured and used.
Consider factors including:
- Intended medical purpose
- Intended users and patient population
- Use environment
- Device classification
- Materials and patient contact
- Sterility requirements
- Reusable or single-use status
- Software functionality
- Electrical or electronic components
- Packaging and shelf-life requirements
- Manufacturing processes
- Applicable regulatory markets
These characteristics help determine which verification and validation activities will be required.
Step 2: Identify Applicable Regulatory Requirements and Standards
Manufacturers should identify the regulatory requirements and standards applicable to the device before establishing the validation programme.
Depending on the device, these may include:
- EU MDR or UK MDR requirements
- ISO 13485 for quality management systems
- ISO 14971 for risk management
- IEC 62304 for medical device software
- IEC 62366-1 for usability engineering
- IEC 60601 series for medical electrical equipment
- ISO 10993 series for biological evaluation
- ISO 11607 series for packaging of terminally sterilised medical devices
- ISO 11135 for ethylene oxide sterilisation
- ISO 11137 series for radiation sterilisation
- ISO 17665 for moist heat sterilisation
- ISO 17664 series for processing information for applicable medical devices
Other product-specific or process-specific standards may also apply.
The standards identified should be assessed for applicability rather than automatically applied to every device.
Step 3: Link Validation to Risk Management
Risk management should be integrated into validation planning from the beginning.
Hazards, hazardous situations and risk control measures identified through the manufacturer’s risk management process can create specific verification requirements.
For example, where a design feature has been introduced as a risk control, the manufacturer should generate objective evidence demonstrating that the control has been correctly implemented and is effective.
Risk analysis can also help identify:
- Critical design characteristics
- Critical process parameters
- Worst-case conditions
- Required test conditions
- Appropriate sample sizes
- Areas requiring more extensive validation
- Acceptance criteria
- Potential triggers for revalidation
This creates traceability between the risk management file and verification and validation evidence.
Step 4: Define Verification and Validation Activities
The manufacturer should determine which activities are required for the particular device.
A validation matrix can be useful for bringing these requirements together.
| Area | Typical Activity | Example Evidence |
|---|---|---|
| Design requirements | Verification | Test reports, inspections and engineering analysis |
| Intended use/user needs | Design validation | Simulated-use or other validation studies |
| Biological safety | Evaluation and testing | Biological Evaluation Report and supporting test reports |
| Software | Verification and validation | Software test and validation records |
| Usability | Formative evaluation and validation | Usability engineering documentation |
| Electrical safety/EMC | Verification testing | IEC 60601 test reports |
| Cleaning | Process/reprocessing validation | Cleaning validation report |
| Sterilisation | Process validation | Sterilisation validation report |
| Packaging | Process/performance validation | Seal, integrity, ageing and distribution evidence |
| Manufacturing processes | Process validation where required | IQ, OQ and PQ records where applicable |
This matrix can then form part of the overall design and development or validation planning process.
Step 5: Establish Acceptance Criteria
Acceptance criteria should be established before testing or validation is performed.
Criteria should be objective, measurable and scientifically justified wherever possible.
They may be derived from:
- Design inputs
- Product specifications
- Risk controls
- Regulatory requirements
- Applicable standards
- Clinical or performance requirements
- Published scientific evidence
- Process capability
- Manufacturer-defined specifications
Defining acceptance criteria retrospectively after seeing the test results can undermine the credibility of the validation exercise.
Step 6: Define Worst-Case Conditions
Validation should consider whether testing under nominal conditions alone provides sufficient evidence.
Where appropriate, manufacturers should identify scientifically justified worst-case conditions.
Examples could include:
- Maximum and minimum process parameters
- Most difficult device configuration
- Largest or smallest product
- Most challenging material
- Highest contamination level
- Most difficult location to clean
- Maximum sterilisation load
- Weakest packaging configuration
- Maximum claimed shelf life
- Environmental extremes within the intended operating range
The selected worst case should be documented and justified.
Step 7: Execute the Validation Protocol
Validation activities should be performed according to an approved protocol or documented test plan.
A validation protocol will typically define:
- Purpose and scope
- Responsibilities
- Equipment and materials
- Applicable procedures
- Test methods
- Sample selection and sample size
- Process parameters
- Worst-case conditions
- Acceptance criteria
- Data to be collected
- Handling of deviations
- Required records and approvals
Any deviation from the approved protocol should be documented, investigated where appropriate and assessed for its potential effect on the validity of the results.
Step 8: Document the Results
The report should clearly demonstrate whether the predefined acceptance criteria were achieved and should normally include:
- Reference to the approved protocol
- Methods performed
- Samples tested
- Actual results
- Deviations
- Statistical analysis where applicable
- Assessment against acceptance criteria
- Conclusions
- Required corrective or follow-up actions
- Approval by authorised personnel
Unsuccessful or unexpected results should not simply be excluded. They should be investigated and appropriately documented.
Step 9: Maintain Validation Throughout the Device Lifecycle
Validation does not end when the initial programme has been successfully completed.
Manufacturers should establish criteria for determining when review or revalidation may be required.
Potential triggers include:
- Design changes
- Material changes
- Supplier changes
- Manufacturing equipment changes
- Process parameter changes
- Software changes
- Changes to sterilisation processes
- Packaging changes
- Changes to cleaning or reprocessing instructions
- Changes to manufacturing location
- Adverse trends or complaints
- CAPA
- New regulatory or standards requirements
The impact of a change should be assessed before implementation to determine whether existing validation remains applicable or whether additional verification or revalidation is required.
Validation Documentation and the Medical Device Technical File
Verification and validation evidence forms an important part of the manufacturer’s technical documentation.
Rather than simply collecting individual test reports, manufacturers should be able to demonstrate a clear chain of evidence from:
Design requirements → Risk analysis → Verification/validation method → Acceptance criteria → Results → Conclusion
For EU MDR devices, Annex II specifically requires the technical documentation to include the results and critical analyses of verification and validation tests and studies undertaken to demonstrate conformity with the Regulation.
A well-structured validation programme therefore provides more than evidence that individual tests have passed. It helps demonstrate systematically that the device has been appropriately designed, its risks have been controlled and the finished product can meet its specified safety and performance requirements.
Common Medical Device Validation Mistakes
Validation problems are frequently caused not by the absence of testing, but by weaknesses in how validation activities are planned, justified, documented and connected to the manufacturer’s wider quality and risk management systems.
These weaknesses can result in gaps in technical documentation and may lead to questions during Notified Body, UK Approved Body or quality management system audits.
Some of the most common validation mistakes include the following.
1. Confusing Verification and Validation
Verification and validation are related but distinct activities.
Verification determines whether specified requirements have been met, while validation demonstrates that the resulting device is capable of meeting the requirements for its intended use.
Manufacturers should clearly identify whether an activity is intended to provide verification evidence, validation evidence or both.
Simply describing all product testing as “validation” can make it difficult to demonstrate appropriate design control and traceability.
2. Testing Without Predefined Acceptance Criteria
One of the most significant weaknesses in a validation study is establishing acceptance criteria after testing has already been completed.
Acceptance criteria should normally be defined and justified before execution of the protocol.
They should be linked, where appropriate, to:
- Design inputs
- Product specifications
- Risk controls
- Applicable standards
- Clinical or performance requirements
- Process specifications
This allows the final report to provide an objective assessment of whether the activity was successful.
3. Failing to Justify Sample Size
Selecting an arbitrary number of samples is rarely a robust approach.
The appropriate sample size will depend on the purpose of the study, variability of the characteristic being evaluated, applicable standards, risk and the type of evidence being generated.
Where statistical methods are appropriate, the manufacturer should define and justify the statistical approach.
Where a non-statistical sample size is used, the rationale should still be documented.
The key requirement is that the evidence generated is sufficient to support the conclusion being made.
4. Inadequate Worst-Case Justification
Manufacturers sometimes state that a particular device, load, configuration or process parameter represents the “worst case” without explaining why.
A worst-case selection should be based on a documented scientific or technical rationale.
Depending on the validation, factors might include:
- Device geometry
- Material characteristics
- Surface area
- Contamination
- Process limits
- Sterilisation load
- Packaging configuration
- Cleaning difficulty
- Environmental conditions
- Maximum claimed shelf life
Where product families are grouped together for validation purposes, the manufacturer should also justify why the selected representative product adequately challenges the process.
5. Treating Validation as a Final Development Activity
Waiting until the end of product development to consider validation can create significant regulatory and commercial problems.
Validation requirements should be considered when establishing design inputs, risk controls, manufacturing processes and regulatory strategy.
Early planning allows manufacturers to identify required testing, suitable samples, applicable standards and acceptance criteria before design decisions become difficult or expensive to change.
6. Poor Traceability
A collection of successful test reports does not necessarily demonstrate an effective verification and validation programme.
Manufacturers should be able to trace relevant requirements through the development process.
For example:
Design input → Risk control → Verification or validation activity → Acceptance criterion → Test result → Conclusion
A verification and validation matrix or design traceability matrix can make this relationship much easier to demonstrate.
7. Using Standards Without Assessing Applicability
Standards provide valuable frameworks and recognised test methods, but manufacturers should not simply compile a list of standards and assume that compliance with them automatically demonstrates regulatory conformity.
Each standard should be assessed for applicability to the particular device, technology and process.
Manufacturers should also identify the appropriate edition of the standard and consider whether amendments, collateral standards or particular standards apply.
Where a standard is only partially applicable, the rationale for the approach should be documented.
8. Failing to Control Validation Equipment and Test Methods
Validation results depend on the reliability of the methods and equipment used to generate them.
Manufacturers should consider whether:
- Measuring equipment is appropriately calibrated
- Test equipment is suitable for its intended purpose
- Test methods are established and controlled
- Personnel are appropriately trained
- Test environments are controlled where necessary
- Software used to generate or analyse validation data is appropriately controlled
If the measurement or test method itself cannot reliably generate valid results, confidence in the resulting validation evidence may be undermined.
9. Ignoring Failed or Unexpected Results
A failed test should not simply be repeated until a passing result is obtained.
Unexpected results, protocol deviations and failures should be documented and investigated appropriately.
The manufacturer should determine whether the result indicates:
- A device design problem
- A manufacturing problem
- An inappropriate acceptance criterion
- A problem with the test method
- An uncontrolled variable
- A risk that has not been adequately addressed
Where testing is repeated, the reason for repeating it and the treatment of the original result should be documented.
10. Failing to Consider Revalidation After Changes
A validation report does not remain valid indefinitely regardless of what subsequently changes.
Changes to the device or manufacturing process should be assessed for their potential effect on previously established validation evidence.
Examples include changes to:
- Materials
- Components
- Suppliers
- Manufacturing equipment
- Production processes
- Software
- Packaging
- Sterilisation
- Cleaning instructions
- Manufacturing sites
- Product specifications
Not every change requires full revalidation. However, the manufacturer should document the assessment and justify whether no additional testing, partial verification or validation, or full revalidation is required.
What Does Good Validation Evidence Look Like?
Strong validation evidence should allow an independent reviewer to understand what was tested, why it was tested, how it was tested, what constituted success and whether those requirements were achieved.
A well-controlled validation package will normally demonstrate:
- A clearly defined purpose and scope
- Appropriate regulatory and standards requirements
- Connection to design inputs and risk controls
- A predefined and approved protocol
- Justified sample selection
- Scientifically justified worst-case conditions where applicable
- Objective acceptance criteria
- Controlled test methods and equipment
- Complete results, including deviations and failures
- A clear conclusion against the acceptance criteria
- Appropriate review and approval
- Traceability into the technical documentation
- Defined requirements for ongoing monitoring or revalidation
The objective is not simply to accumulate test reports. The validation evidence should collectively demonstrate that the manufacturer’s conclusions about the device or process are supported by objective, traceable and reproducible evidence.
When Is Medical Device Revalidation Required?
Validation is not a one-time activity. Once a device or process has been validated, manufacturers must ensure that the original validation remains applicable throughout the product lifecycle.
Changes, new information or evidence of process deterioration can affect the assumptions on which the original validation was based. Manufacturers should therefore establish documented criteria for determining when validation evidence needs to be reviewed and when revalidation is necessary.
Changes That May Trigger Revalidation
A review of existing validation should be considered following changes such as:
- Device design changes
- Changes to materials or components
- Changes of critical suppliers
- Manufacturing equipment changes
- Changes to manufacturing processes or process parameters
- Transfer to a different manufacturing site
- Changes to production software or automated systems
- Sterilisation process changes
- Changes to sterilisation suppliers or facilities
- Packaging material or configuration changes
- Changes to sealing equipment or parameters
- Changes to cleaning or reprocessing procedures
- Changes to the claimed shelf life
- Changes to storage or transportation conditions
- Changes to the device’s intended purpose or use environment
The presence of a change does not automatically mean that the entire validation programme must be repeated.
Instead, the manufacturer should assess the potential impact of the change and determine the extent of additional verification or validation required.
Using Change Control to Determine Revalidation
Revalidation should be closely integrated with the manufacturer’s change-control process.
Before implementing a significant change, the manufacturer should assess questions such as:
- Does the change affect a previously verified design requirement?
- Does it affect a previously validated user need or intended use?
- Could it affect an existing risk control?
- Does it alter a critical process parameter?
- Does it affect the assumptions or worst-case conditions used during the original validation?
- Does it affect compliance with an applicable regulatory requirement or standard?
- Does it introduce a new hazard or change an existing risk?
- Does the existing validation evidence remain representative of the changed device or process?
The outcome of this assessment should be documented.
Depending on the impact of the change, the conclusion may be that:
- Existing validation remains applicable
- Limited additional verification is required
- Partial revalidation is required
- Full revalidation is required
This risk-based approach helps avoid unnecessary repetition while ensuring that changes capable of affecting device safety, performance or process consistency are adequately evaluated.
Periodic Review of Validated Processes
Revalidation should not only be considered when a deliberate change is made.
Manufacturers should also monitor validated processes to ensure that they continue to operate in a state of control.
Information used to assess ongoing process performance may include:
- Process monitoring data
- Production records
- Nonconformities
- Deviations
- Equipment maintenance records
- Calibration results
- Environmental monitoring
- Complaint data
- CAPA
- Internal audit findings
- Supplier performance
- Post-market surveillance information
Adverse trends may indicate that a previously validated process is no longer consistently producing the expected output.
Revalidation Following Process Drift
A process can gradually change even where no formal change has been introduced.
Equipment wear, environmental conditions, raw material variability, supplier changes and other factors can contribute to process drift.
Statistical monitoring and process-performance data can therefore play an important role in identifying deterioration before it results in unacceptable product.
Where evidence indicates that the validated operating state may no longer be maintained, manufacturers should investigate the cause and determine whether corrective action and revalidation are necessary.
Revalidation Following Regulatory or Standards Changes
Changes to regulations, standards or regulatory expectations may also require existing validation evidence to be reviewed.
A new or revised standard does not necessarily mean that all previous testing must automatically be repeated. Manufacturers should perform a documented gap assessment to determine:
- What has changed
- Whether the change applies to the device
- Whether existing evidence addresses the revised requirements
- Whether additional testing or validation is required
- Whether technical documentation needs to be updated
This assessment should form part of the manufacturer’s regulatory change-management process.
Validation Throughout the Medical Device Lifecycle
An effective validation system therefore operates throughout the entire medical device lifecycle.
A simplified approach is:
Design inputs and user needs
↓
Risk assessment
↓
Verification and validation planning
↓
Testing and process validation
↓
Technical documentation and market access
↓
Routine production and process monitoring
↓
Post-market surveillance and feedback
↓
Change control and validation review
↓
Revalidation where required
This lifecycle approach helps ensure that validation evidence continues to represent the device that is actually being manufactured and placed on the market, rather than only the version that existed when the original validation studies were performed.
Medical Device Validation Documentation and Records
Effective validation depends not only on performing appropriate testing, but also on maintaining sufficient documentation to demonstrate how the validation was planned, conducted, assessed and approved.
Validation records should provide a clear audit trail from the original requirement through to the evidence demonstrating that the requirement has been satisfied.
For manufacturers operating under ISO 13485, these records should be controlled within the quality management system and retained in accordance with applicable regulatory and document-control requirements.
Validation Strategy or Validation Master Plan
For devices involving multiple validation activities or complex manufacturing processes, manufacturers may benefit from establishing an overall validation strategy or Validation Master Plan (VMP).
There is no requirement for every medical device manufacturer to have a document specifically called a “Validation Master Plan”. The important requirement is that validation activities are appropriately planned and controlled.
A validation strategy may identify:
- Devices and processes within scope
- Responsibilities
- Applicable regulatory requirements
- Applicable standards
- Verification and validation activities
- Processes requiring validation
- Validation methods
- Relationships between different validation activities
- Required protocols and reports
- Documentation and approval requirements
- Change-control arrangements
- Revalidation criteria
For simpler devices, the same information may instead be incorporated within the design and development plan, quality plan or individual validation protocols.
Validation Protocol
Before performing a validation study, the manufacturer should establish an approved protocol or equivalent documented plan.
The protocol defines what will be done and, importantly, what constitutes a successful result.
A typical validation protocol may contain:
- Document number and revision
- Purpose
- Scope
- Responsibilities
- Device or process being evaluated
- Applicable procedures and standards
- Equipment and materials
- Product or sample selection
- Sample-size rationale
- Test methods
- Process parameters
- Worst-case conditions and their justification
- Acceptance criteria
- Statistical methods, where applicable
- Data-recording requirements
- Deviation handling
- Required approvals
The level of detail should be proportionate to the complexity and risk associated with the validation.
Raw Data and Supporting Evidence
The validation report should be supported by the underlying evidence generated during the study.
Depending on the validation, this might include:
- Laboratory data
- Equipment outputs
- Measurement results
- Environmental monitoring records
- Calibration records
- Photographs
- Software-generated records
- Batch or manufacturing records
- Certificates and external laboratory reports
- Statistical analyses
- Operator records
- Inspection results
Records should be attributable to the activity performed and maintained in a manner that preserves their integrity and traceability.
Validation Deviations
Deviations from an approved protocol should be documented rather than omitted from the final validation record.
For each significant deviation, the manufacturer should consider:
- What occurred
- Why it occurred
- Whether an investigation is necessary
- Whether the deviation affected the validity of the results
- Whether corrective action is required
- Whether testing needs to be repeated
- Whether the validation conclusion remains supported
The assessment and justification should be documented.
Validation Report
Once the protocol has been completed, the results should be assessed in a validation report.
The report should provide sufficient information for an independent reviewer to determine whether the validation was successfully completed.
A typical report may include:
- Reference to the approved protocol
- Description of the validation performed
- Dates and locations
- Devices, batches or samples evaluated
- Equipment used
- Actual process parameters
- Test results
- Statistical analysis where applicable
- Deviations and investigations
- Assessment against each acceptance criterion
- Discussion of unexpected findings
- Overall conclusion
- Follow-up actions
- Approval by authorised personnel
The conclusion should be supported by the results rather than simply stating that the process or device “passed validation”.
Verification and Validation Traceability
Traceability is particularly important within medical device design and development.
Manufacturers should be able to demonstrate the relationship between requirements and the evidence used to verify or validate them.
A simple traceability structure could look like this:
| Requirement | Risk / Control | V&V Activity | Acceptance Criteria | Evidence | Result |
|---|---|---|---|---|---|
| Design input | Applicable risk control | Verification test | Defined specification | Test report | Pass/Fail |
| User need | Applicable risk | Design validation | Defined user requirement | Validation report | Pass/Fail |
| Sterility requirement | Infection risk control | Sterilisation validation | Defined process requirements | Validation report | Pass/Fail |
| Package integrity | Loss of sterile barrier | Packaging validation | Defined integrity criteria | Test report | Pass/Fail |
A traceability matrix can be particularly useful for demonstrating that all applicable design requirements and risk controls have been addressed before design transfer or regulatory submission.
Validation Documentation Within the Technical File
Validation records also provide important evidence for the medical device technical documentation.
Under the EU MDR, Annex II requires technical documentation to contain the results and critical analyses of verification and validation tests and studies undertaken to demonstrate conformity with the Regulation.
Depending on the device, the technical documentation may therefore reference or contain evidence relating to:
- Design verification and validation
- Biological evaluation
- Electrical safety and EMC
- Software verification and validation
- Usability engineering
- Cleaning and reprocessing
- Sterilisation
- Packaging
- Shelf-life
- Transportation
- Performance testing
- Clinical evaluation
The technical documentation should allow the manufacturer — and where applicable a Notified Body or regulatory authority — to understand how the evidence collectively demonstrates conformity.
A Clear Validation Document Hierarchy
For many manufacturers, the validation documentation can be organised using the following structure:
Validation strategy / plan
↓
Validation protocol
↓
Execution and raw data
↓
Deviations and investigations
↓
Validation report
↓
Traceability to requirements and risks
↓
Technical documentation
↓
Change control and revalidation
The exact document names are less important than maintaining a controlled, traceable and scientifically justified body of evidence demonstrating that the required verification and validation activities have been successfully completed.
Medical Device Validation and Notified Body Expectations
For medical devices requiring third-party conformity assessment, verification and validation evidence will form an important part of the technical documentation reviewed by the Notified Body.
The purpose of the assessment is not simply to confirm that testing has been performed. The reviewer needs to determine whether the manufacturer has identified the appropriate verification and validation requirements, used suitable methods and generated sufficient objective evidence to demonstrate conformity.
A well-structured validation package should therefore allow an assessor to follow the reasoning from the device requirements and identified risks through to the final validation conclusions.
What Will a Notified Body Look for?
The precise level of scrutiny will depend on the device, its classification, technology, intended purpose and associated risks. However, manufacturers should be prepared to demonstrate areas such as:
- A defined verification and validation strategy
- Traceability to design inputs and user needs
- Integration with ISO 14971 risk management
- Identification of applicable regulatory requirements
- Appropriate use of harmonised standards and other recognised standards
- Approved protocols or test plans
- Predefined acceptance criteria
- Justification of test methods
- Appropriate sample-size rationale
- Identification and justification of worst-case conditions
- Suitable test equipment and methods
- Complete test results and supporting evidence
- Appropriate treatment of deviations and failures
- Clear conclusions against acceptance criteria
- Evidence that risk controls have been verified
- Appropriate review and approval
- Assessment of changes and revalidation requirements
The manufacturer should also be able to explain why particular validation activities were considered necessary — and why others were considered not applicable.
Traceability Is Critical
One of the most important features of strong verification and validation documentation is traceability.
An assessor should be able to follow a logical pathway such as:
User need
↓
Design input
↓
Associated risk or risk control
↓
Verification or validation requirement
↓
Test method and acceptance criteria
↓
Result
↓
Objective evidence
↓
Conclusion
Gaps in this chain can make it difficult to demonstrate that all relevant requirements have been adequately addressed.
For example, a manufacturer may have an electrical safety test report demonstrating compliance with an applicable standard. However, the technical documentation should also make clear which device requirements and risk controls that evidence supports.
Acceptance Criteria Must Be Defined in Advance
Notified Body reviewers may scrutinise whether acceptance criteria were established before testing was performed.
Validation protocols should define what constitutes an acceptable outcome wherever practicable.
Acceptance criteria should also have an appropriate basis. Depending on the activity, this could include:
- Regulatory requirements
- Applicable standards
- Design specifications
- Risk-control requirements
- Clinical requirements
- Performance requirements
- Process specifications
- Scientific evidence
An unexplained pass/fail criterion may be difficult to defend even where the test result itself is favourable.
Sample Size Should Be Justified
Another common area of scrutiny is sample size.
There is no universal sample size that applies to all medical device verification and validation activities.
The manufacturer should instead consider the nature of the test, device risk, expected variability, applicable standards and whether statistical methods are appropriate.
Where three samples have been tested, for example, the justification should not simply be that “three samples are normally used.”
The rationale should explain why the selected sample size provides sufficient evidence to support the conclusion being made.
Worst-Case Selection Must Be Defensible
Worst-case testing can allow a manufacturer to generate evidence covering multiple products, configurations or operating conditions without testing every possible combination.
However, the selected worst case must be justified.
For example, the most challenging configuration for cleaning validation may not be the same configuration that represents the worst case for sterilisation or packaging validation.
Worst-case selection should therefore be specific to the characteristic or process being evaluated.
Test Reports Must Represent the Marketed Device
Manufacturers should ensure that verification and validation evidence remains representative of the device being placed on the market.
Particular attention should be given where testing was conducted using:
- Prototypes
- Pre-production devices
- Different materials
- Different components
- Different software versions
- Different manufacturing processes
- Different packaging configurations
- Different sterilisation processes
Where representative rather than final production devices are used, the manufacturer should document why the samples are sufficiently representative and assess whether subsequent changes affect the validity of the evidence.
Standards Do Not Replace the Manufacturer's Assessment
Testing against a recognised standard can provide powerful evidence of conformity, but the presence of a successful test report does not remove the manufacturer’s responsibility to assess the device as a whole.
Manufacturers should determine:
- Whether the standard is applicable
- Which clauses apply
- Whether deviations or exclusions require justification
- Whether additional device-specific requirements exist
- Whether additional testing is required
- Whether the tested configuration represents the marketed device
This is particularly important where several standards interact or where the standard does not address every risk associated with the device.
Validation Deficiencies Can Lead to Regulatory Questions
Weak verification or validation evidence can result in questions or nonconformities during technical documentation assessment.
Typical weaknesses include:
- Missing validation activities
- Poor traceability
- Undefined acceptance criteria
- Inadequate sample-size rationale
- Unsupported worst-case assumptions
- Testing against obsolete or inappropriate standards
- Incomplete protocols
- Unexplained deviations
- Inconsistent device configurations across reports
- Failure to connect testing with risk controls
- Insufficient evidence following design or process changes
Addressing these issues during development is generally far more efficient than trying to reconstruct validation justifications during conformity assessment.
Preparing Validation Evidence for Regulatory Review
Before submitting technical documentation for conformity assessment, manufacturers should perform a structured review of their verification and validation evidence.
A useful final check is to ask:
Can we demonstrate what needed to be verified or validated, why it was required, how we evaluated it, what constituted success, what the results were, and how those results support the safety and performance of the final device?
If those relationships can be clearly demonstrated throughout the technical documentation, the validation package is much easier for an independent assessor to review.
Preparing for a Notified Body Assessment?
Verification and validation evidence forms an important part of the Technical Documentation assessed during EU MDR conformity assessment. Learn more about Technical Documentation reviews, Quality Management System audits, conformity assessment routes and certification in our Complete Guide to Medical Device Notified Bodies.
How Patient Guard Can Help with Medical Device Validation
Developing an effective medical device validation strategy requires more than completing a series of tests. Manufacturers need to identify the applicable regulatory and standards requirements, determine which verification and validation activities are necessary, establish appropriate acceptance criteria and ensure that the resulting evidence is suitable for inclusion within the technical documentation.
Patient Guard can support manufacturers throughout this process, from initial validation planning through to review of completed evidence and preparation for conformity assessment.
Validation Strategy and Gap Assessment
We can review your device, intended purpose, manufacturing processes and existing documentation to identify the verification and validation activities that may be required.
This can include:
- Review of existing verification and validation evidence
- Identification of gaps within the technical documentation
- Assessment of applicable standards
- Review of validation strategies and plans
- Identification of processes requiring validation
- Risk-based assessment of validation requirements
- Review of legacy validation evidence
- Assessment of validation requirements following device or process changes
Where existing evidence is available, our approach is to determine whether it remains suitable and identify genuine gaps rather than automatically recommending that testing is repeated.
Validation Protocol Development and Review
Patient Guard can support the preparation or independent review of validation protocols before testing begins.
This may include reviewing:
- Validation scope
- Applicable standards
- Test methodology
- Product and sample selection
- Sample-size rationale
- Worst-case selection
- Process parameters
- Acceptance criteria
- Statistical methods
- Deviation procedures
- Documentation requirements
Establishing these requirements before testing can reduce the risk of generating evidence that is subsequently insufficient for regulatory purposes.
Review of Validation Reports and Evidence
Where validation has already been performed, we can review the resulting documentation to assess whether it adequately supports the manufacturer’s regulatory conclusions.
This can include:
- Validation reports
- Laboratory test reports
- Sterilisation validation
- Cleaning validation
- Packaging validation
- Shelf-life studies
- Electrical safety and EMC reports
- Software verification and validation
- Usability validation
- Manufacturing process validation
Any identified gaps can then be addressed before technical documentation is submitted for conformity assessment.
Technical Documentation Integration
Validation evidence should not sit in isolation from the rest of the medical device technical file.
Patient Guard can help manufacturers establish traceability between:
Device requirements → Risk controls → Verification and validation → Objective evidence → Regulatory conformity
This can include integrating validation evidence with:
- Technical documentation
- Risk management files
- Design and development records
- Biological evaluation
- Clinical evaluation
- Software documentation
- Usability engineering
- Post-market surveillance documentation
This integrated approach makes it easier to demonstrate how the evidence supports the overall safety and performance of the medical device.
Support for EU MDR and UK MDR Compliance
Patient Guard supports manufacturers developing devices for the European Union and Great Britain.
Our wider medical device regulatory services include:
- EU MDR and UK MDR regulatory strategy
- Device classification
- Technical Documentation preparation and review
- ISO 13485 QMS implementation
- ISO 14971 risk management
- Clinical Evaluation Plans and Reports
- Biological Evaluation Plans and Reports
- Software regulatory documentation
- Post-market surveillance and PMCF
- Notified Body and UK Approved Body preparation
- EU Authorised Representative services
- UK Responsible Person services
Whether you are developing a new medical device, addressing gaps in an existing technical file or preparing for conformity assessment, we can help ensure that verification and validation activities are appropriately planned, documented and incorporated into your regulatory evidence.
Need Help with Medical Device Validation?
If you are unsure which validation activities apply to your device, have received questions about existing validation evidence, or need support preparing your technical documentation, Patient Guard can review your current position and develop a practical route forward.
Frequently Asked Questions About Medical Device Validation
Medical device validation is the documented process of demonstrating, through objective evidence, that a medical device, manufacturing process or supporting system consistently performs as intended and meets predefined acceptance criteria. Validation is a key requirement under ISO 13485 and supports compliance with the EU MDR and UK medical device regulations.
Verification confirms that a medical device has been designed and manufactured according to its specified requirements, while validation demonstrates that the finished device or process consistently fulfils its intended purpose under actual or simulated conditions of use. Both activities are essential for regulatory compliance.
The type of validation required depends on the device and manufacturing process but commonly includes cleaning validation, packaging validation, sterilization validation, electrical safety testing, software validation, transport validation and shelf-life studies. Manufacturers should determine validation requirements using a risk-based approach.
Yes. The EU Medical Device Regulation (EU MDR 2017/745) requires manufacturers to generate objective evidence demonstrating that medical devices are safe, perform as intended and continue to comply throughout their lifecycle. Validation supports these requirements alongside clinical evaluation, risk management and technical documentation.
ISO 13485 requires manufacturers to validate processes where the results cannot be fully verified by subsequent inspection or testing. The standard also requires validation activities to be planned, documented, reviewed and maintained as part of the Quality Management System (QMS).
Revalidation should be considered whenever significant changes occur that could affect product quality, safety or performance. Examples include manufacturing process changes, equipment replacement, packaging modifications, sterilization changes, software updates, supplier changes or manufacturing site transfers.
Validation documentation typically includes a Validation Master Plan (VMP), validation protocols, acceptance criteria, risk assessments, test results, deviation records, validation reports and approval records. This documentation should be maintained within the manufacturer’s Quality Management System and Technical Documentation.
Electrical safety testing validates that active medical devices continue to operate safely under both normal and fault conditions. Testing against standards such as IEC 60601-1 provides objective evidence that electrical hazards have been controlled and that the device remains safe for its intended use.
Validation provides objective evidence that risk control measures are effective. Activities such as cleaning validation, sterilization validation and packaging validation demonstrate that identified risks have been reduced to acceptable levels in accordance with ISO 14971 and should be referenced within the manufacturer’s Risk Management File.
Yes. Patient Guard provides regulatory and quality consultancy covering validation strategy, validation protocols, cleaning validation, packaging validation, sterilization validation, electrical safety support, ISO 13485 implementation, ISO 14971 risk management and Technical Documentation to help manufacturers achieve and maintain regulatory compliance.
References
This guide is based on current medical device legislation, quality management requirements and international standards relevant to verification and validation, process validation, risk management, packaging, sterilisation and conformity assessment.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (EU MDR) | Establishes the EU regulatory framework for medical devices. Annex II requires technical documentation to include product verification and validation evidence, while Annex I establishes the applicable General Safety and Performance Requirements. |
| UK Government / MHRA | Medical Devices: Conformity Assessment and the UKCA Mark | Provides MHRA guidance on conformity assessment for medical devices in Great Britain and explains the use of designated standards, including ISO 13485, ISO 14971 and process-specific standards supporting UK MDR compliance. |
| UK Government | Designated Standards: Medical Devices | Provides the current notices and consolidated list of standards designated in support of the UK Medical Devices Regulations 2002 for Great Britain. |
| ISO | ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes | Establishes the internationally recognised quality management system requirements for medical device manufacturers, including design and development verification, design validation and validation of production and service processes. |
| ISO | ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices | Establishes the risk management process used to identify hazards, evaluate risks, implement risk controls and verify the effectiveness of those controls throughout the medical device lifecycle. |
| ISO | ISO 11607-1:2019 – Packaging for Terminally Sterilized Medical Devices – Part 1 | Specifies requirements and test methods for materials, sterile barrier systems and packaging systems intended to maintain the sterility of terminally sterilised medical devices until the point of use. |
| ISO | ISO 11607-2:2019 – Packaging for Terminally Sterilized Medical Devices – Part 2 | Establishes validation requirements for forming, sealing and assembly processes used for sterile barrier systems and packaging systems. |
| ISO | ISO 11135:2014 – Sterilization of Health-Care Products – Ethylene Oxide | Specifies requirements for the development, validation and routine control of ethylene oxide sterilisation processes for medical devices. |
| ISO | ISO 11137-1:2025 – Sterilization of Health Care Products – Radiation – Part 1 | Specifies requirements for the development, validation and routine control of radiation sterilisation processes used for medical devices. |
| ISO | ISO 17665:2024 – Sterilization of Health Care Products – Moist Heat | Specifies requirements for the development, validation and routine control of moist heat sterilisation processes for medical devices. |
The standards applicable to a medical device validation programme depend on the device, intended purpose, manufacturing processes, risks and regulatory markets. Manufacturers should assess applicability and confirm the current edition and regulatory status of each standard before use.
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