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April 2024 – News Letter

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Message from our Founder

Dear Valued Clients and Partners,

As we step into the spring of 2024, we are delighted to present the latest edition of Patient Guard’s Newsletter, dedicated to providing you with insightful updates and invaluable resources in medical device and In Vitro Diagnostics (IVD) regulatory affairs and quality assurance consultancy.

We have been busy updating our website to change it from a generic consultancy website to an informative resource for medical device and IVD information. We also attended the Medical Technology Exhibition in Coventry in March, where we met lots of people with new and interesting medical device ideas they are developing.

We will be attending the Medtech Exhibition at Birmingham NEC arena in June 2024.

We wish you a lovely April and look forward to engaging with you soon.

Best wishes

David Small – Founder of Patient Guard

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Regulatory News

EU

UK

USA

Important Deadline - 26th May 2024

If you currently sell CE marked legacy devices under MDD in the EU or the UK which requires a Notified Body under MDR, then you must have a contract in place with a Notified Body for MDR to take advantage of the certificate extensions under article 120 to allow you to continue to place your devices on the market under MDD until 2027/2028.

CE marked devices under MDD in the UK which require a Notified Body must upload their extension certificates on the MHRA portal to remain compliant.

This does not apply to UKCA marked devices or devices that do not require a Notified Body under CE marking.

New medical devices are required to follow MDR for CE marking.

red caution symbol used to explain medical device risk management in line with ISO 14971 on Patient Guards medical device consultancy risk management blog.
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Updated MDCG Guidlines

  • MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices

MDCG

Updated MHRA Guidelines

  • Notify the MHRA about a clinical investigation for a medical device

MHRA
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Patient Guards latest news letters detailing all the latest medical device and IVD regulatory updates and standards updates.

New/updated Standards issued

  • ISO 17665:2024 – Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

  • IEC 80601-2-58:2024 – Medical electrical equipment. – Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

  • ISO 18562-4:2024 – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Tests for leachables in condensate

  • BS EN ISO 20916:2024 – In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

  • BS EN IEC 80601-2-26:2020+A1:2024 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of electroencephalographs

  • BS ISO 5832-11:2024 – TC – Implants for surgery. Metallic materials – Wrought titanium 6-aluminium 7-niobium alloy

Our Latest Videos

ISO 14971 and the Risk Management of Medical Devices plays an integral part of demonstrating product safety throughout the life cycle of medical devices. In fact, the focus of all global medical device regulations relate to risk and how these are mitigated, to demonstrate that the clinical benefit of using the medical device outweighs the risks associated with using the medical device. ISO 14971 is an international standard, a set of ‘state of the art’ and best practice principles adopted by medical device manufacturers. The standard sets out how risks should be identified, assessed for severity and likelihood of occurrence, applying control measures, re-assessment of the risk once control measures are in place, evaluation of residual risks introduced by control measures. It provides a framework to follow to assess risk at each stage of the product life cycle: * Design * Manufacturing * Packaging * Transport * Storage * Use * Obsolescence/disposal The standard is a harmonised/consensus standard. This means that it should be used to demonstrate medical device compliance for the aspects of risk management in accordance with medical device regulations. This includes EU MDR 2017/745, EU IVDR 2017/746, UK MDR 2002 and FDA CFR 21. The first aspect to consider when implementing ISO 14971 is planning. A risk management plan should be developed to demonstrate how risk management will take place. This should be a set of instructions detailing in what form risk management activities will be conducted, the type of risk management principles that will be applied (FMEA for example). It should set out the criteria for what constitutes an acceptable risk compared to an unacceptable risk, and what the actions are based on the risk acceptability criteria. The risk management plan should include the stages at which risk management should take place, and who should be involved in risk management activities. It should also include when and how risk management should take place in relation to post market surveillance and vigilance activities, such as if there was an adverse incident relating to the use of the medical device, that was not foreseen when originally assessing the risks of the medical device. The aim of the plan is to ensure that medical device manufacturers reduce risks to as low as possible. Risk management is an ongoing process and documentation continually kept up to date within the risk management file. Each medical device type should have its own risk management documentation, this is usually kept with the technical documentation in the medical device file. Manufacturers of medical devices are responsible for identifying all the known and foreseeable risks associated with the use of the medical device both within its intended use and misuse of the medical device, the risks should be assessed in both normal and fault conditions. Once risks have been identified they should be assessed based on their severity and likelihood of occurrence. They should also be assessed for acceptability based on the level of risk identified. One way this can be done is through FMEA. Severity is given a number of 1 to 5, with 1 being the lowest risk and 5 being the highest risk and the same for likelihood of occurrence. Its important to remember that the severity of the identified risk will always be the same even after control measures have been put in place, but the likelihood of risk can be moved to a lower number once mitigated and controlled. Once risk control and mitigation factors have been put in place, the manufacturer should assemble the risk management team to evaluate the risk control measures to ensure that the risk has been reduced to as low as possible. They should also evaluate any residual risks that remain after the control measures have been put in place by performing the risk analysis of the control measure against the original risk identified. If the control measures do not mitigate the risk to an acceptable level, then they should take action such as redesign, changes in manufacturing and so on, and then assess the risk again. Once the device is in its final finished form ready for release. The Risk Management Team should evaluate the over all risk documentation that has been generated and evaluate if the residual risks are acceptable and that all residual risk information where a risk is still possible is documented either on the medical device labelling in the form of symbols following ISO 15223-1, and in the instructions for use, providing the end user with important information on how to use the device safely. #riskmanagement #iso14971 #medicaldeviceregulation #medicaldevices #medicalinnovation #medicaltechnology #medicaldevicecompliance www.patientguard.com
ISO 14971 and the risk management of medical devices
IEC 62366-1 is a standard related to usability engineering for medical devices. It provides guidance on how to apply human factors engineering to the design and evaluation of medical devices to ensure their usability and safety. Here's an overview of the key points covered in IEC 62366-1: 1. **Scope**: The standard applies to the process of designing, evaluating, and improving the usability of medical devices to minimize the risks associated with their use. 2. **Definitions**: It provides definitions for various terms used in the context of usability engineering, such as usability, user interface, and user error. 3. **Usability Engineering Process**: IEC 62366-1 outlines a systematic process for integrating human factors engineering principles into the design and development of medical devices. This process includes the following key steps: - Planning usability activities - Conducting a preliminary analysis of use-related hazards - Establishing user requirements - Designing user interfaces - Conducting formative evaluation (testing during the design process) - Conducting summative evaluation (testing after the design process) - Evaluating residual risks - Documenting the usability engineering process 4. **User Interface Design**: The standard emphasizes the importance of designing user interfaces that are intuitive, easy to learn, and efficient to use. It provides guidance on factors such as control labeling, layout, and feedback mechanisms. 5. **Usability Testing**: IEC 62366-1 encourages the use of both formative and summative usability testing to evaluate the effectiveness and safety of medical device user interfaces. It provides guidance on conducting these tests, including selecting appropriate test participants and scenarios. 6. **Risk Management**: The standard integrates usability engineering into the overall risk management process for medical devices. It emphasizes the importance of identifying and mitigating use-related hazards through usability activities. 7. **Documentation Requirements**: IEC 62366-1 specifies the documentation that should be maintained throughout the usability engineering process, including records of user research, design iterations, and usability test results. Overall, IEC 62366-1 serves as a valuable resource for medical device manufacturers seeking to improve the usability and safety of their products through human factors engineering principles. Compliance with this standard can help ensure that medical devices meet the needs of users and minimize the risk of user errors. #medicaldeviceregulation #medicaldevices #medicalinnovation #euregulations #medtech #medicaldevicecompliance #medicaltechnology #healthtech https://patientguard.com
IEC 62366 1 Usability Engineering for Medical Devices
Sterilization of medical devices is a critical process aimed at eliminating or destroying all forms of microbial life, including bacteria, viruses, fungi, and spores, from the surface or material of the device. This is essential to prevent infection and ensure the safety of patients undergoing medical procedures. There are several methods commonly used for sterilizing medical devices: 1. **Steam Sterilization (Autoclaving)**: This method utilizes high-pressure steam to achieve sterilization. It is one of the most commonly used and effective methods for heat-resistant medical devices. Autoclaves are machines designed to create the necessary conditions of high temperature (usually around 121-134°C) and pressure to kill microorganisms. 2. **Ethylene Oxide (ETO) Sterilization**: Ethylene oxide gas is a highly effective method for sterilizing heat-sensitive medical devices, such as plastic or electronic components, that cannot withstand the high temperatures of steam sterilization. ETO penetrates packaging and kills microorganisms through alkylation of proteins and nucleic acids. However, ETO requires careful handling due to its toxicity, flammability, and potential residual hazards. 3. **Gamma Radiation Sterilization**: Gamma radiation, emitted from a radioactive isotope such as cobalt-60 or cesium-137, is used to sterilize medical devices. This method disrupts the DNA of microorganisms, preventing them from reproducing. Gamma radiation can penetrate packaging materials, making it suitable for sterilizing pre-packaged devices. However, it may degrade certain materials and can be costly to implement. 4. **Electron Beam (E-beam) Sterilization**: Similar to gamma radiation, electron beam sterilization uses a beam of high-energy electrons to disrupt microbial DNA. It is effective for sterilizing both packaged and unpackaged medical devices and is suitable for heat-sensitive materials. However, like gamma radiation, it can cause material degradation and requires specialized equipment. 5. **Dry Heat Sterilization**: Dry heat sterilization involves exposing medical devices to high temperatures (usually around 160-180°C) for an extended period. This method is effective for heat-stable materials but may take longer than steam sterilization. Dry heat penetrates materials more slowly than moist heat, and it may not be suitable for some types of medical devices. 6. **Chemical Sterilization**: Various chemical agents, such as hydrogen peroxide, peracetic acid, and chlorine dioxide, can be used for sterilization. These methods are often used for sterilizing endoscopes and other heat-sensitive medical devices. Chemical sterilants work by denaturing proteins and disrupting microbial cell membranes. Care must be taken to ensure thorough rinsing to remove residual chemicals. Each sterilization method has its advantages and limitations, and the choice depends on factors such as the type of medical device, material compatibility, efficacy requirements, and regulatory considerations. Validation studies are necessary to demonstrate the effectiveness of the chosen sterilization process for a particular medical device. #sterilization #medicaldeviceregulation #medicaldevices #euregulations #healthcare #medtech https://patientguard.com
The sterilisation of medical devices and the methods used
Medical device labeling is a critical aspect of ensuring patient safety, regulatory compliance, and effective communication between healthcare professionals, patients, and manufacturers. Proper labeling provides essential information about the device, including its intended use, instructions for use, potential risks, and other important details. One standard widely used in medical device labeling is ISO 15223-1. ISO 15223-1, titled "Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied," is an international standard developed by the International Organization for Standardization (ISO). It provides guidelines for the use of symbols on medical device labels, packaging, and accompanying documentation to convey information consistently and universally. Here are some key aspects of ISO 15223-1 and its importance in medical device labeling: 1. **Standardization of Symbols**: ISO 15223-1 standardizes the symbols used on medical device labels to ensure clarity and consistency across different devices and manufacturers. This standardization helps prevent confusion and enhances understanding among users, regardless of their language or cultural background. 2. **Compliance with Regulatory Requirements**: Many regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Union's CE marking system, require medical device manufacturers to use symbols in accordance with ISO 15223-1. Adhering to this standard helps manufacturers demonstrate compliance with regulatory requirements, streamlining the approval process for their devices. 3. **Enhanced Communication**: Medical devices often need to convey complex information in a concise and easily understandable manner. ISO 15223-1 provides a set of internationally recognized symbols that can effectively communicate essential information such as warnings, instructions for use, and device characteristics. This enhances communication between manufacturers, healthcare professionals, and end-users, reducing the risk of errors or misuse. 4. **Facilitation of Global Trade**: With medical devices being manufactured and distributed globally, standardizing labeling requirements is crucial for facilitating trade and ensuring product accessibility across different markets. ISO 15223-1 helps harmonize labeling practices, making it easier for manufacturers to navigate international regulatory frameworks and expand their market reach. 5. **Continuous Improvement**: ISO standards are periodically reviewed and updated to reflect advances in technology, changes in regulatory requirements, and feedback from stakeholders. Medical device manufacturers are encouraged to stay updated with the latest revisions of ISO 15223-1 to ensure their labeling practices remain compliant and reflect best practices in the industry. In conclusion, ISO 15223-1 plays a vital role in medical device labeling by standardizing the use of symbols to convey essential information effectively and consistently. Compliance with this standard not only facilitates regulatory approval but also enhances communication, patient safety, and global market access for medical devices. #medicaldeviceregulation #medicaldevices #medicaldevicecompliance #labelling #medtech www.patientguard.com
Medical Device Labelling - ISO 15223 Medical Symbols
Medical device electrical safety is paramount in the healthcare industry, ensuring the protection of patients, healthcare professionals, and the general public from potential hazards associated with electrical devices used in medical settings. From diagnostic equipment to life-saving devices, electrical safety standards are rigorously enforced to minimize risks and ensure optimal performance. Here's a comprehensive overview of the key aspects: ### Importance of Electrical Safety in Medical Devices: 1. **Patient Safety**: Medical devices are often directly connected to patients or used in close proximity to them. Any malfunction or electrical hazard could pose serious risks to patient safety, including electric shock, burns, or interference with bodily functions. 2. **Reliability**: Reliable electrical systems in medical devices are essential for accurate diagnosis, treatment, and monitoring of patients. Malfunctions due to electrical issues can lead to incorrect readings or ineffective treatment, compromising patient care. 3. **Regulatory Compliance**: Regulatory bodies such as the FDA (Food and Drug Administration) in the United States and the CE (Conformité Européenne) mark in Europe impose stringent electrical safety standards for medical devices. Compliance with these standards is not only mandatory but also ensures the devices meet minimum safety requirements. ### Key Aspects of Medical Device Electrical Safety: 1. **Design and Engineering**: Medical device manufacturers must adhere to specific design and engineering principles to ensure electrical safety. This includes using appropriate materials, insulation, and circuitry to prevent electrical hazards. 2. **Electrical Standards and Regulations**: Medical devices must comply with relevant electrical safety standards and regulations, such as IEC 60601-1 (International Electrotechnical Commission) and ANSI/AAMI ES60601-1 (American National Standards Institute/Association for the Advancement of Medical Instrumentation). These standards outline requirements for insulation, grounding, leakage currents, and more. 3. **Risk Assessment**: Manufacturers conduct thorough risk assessments to identify potential electrical hazards associated with their devices. This includes analyzing possible failure modes, conducting fault simulations, and implementing mitigation strategies to minimize risks. 4. **Testing and Certification**: Medical devices undergo rigorous testing procedures to evaluate their electrical safety performance. This includes insulation resistance testing, leakage current measurements, dielectric strength testing, and ground continuity checks. Certification by accredited testing laboratories is necessary to demonstrate compliance with electrical safety standards. 5. **Maintenance and Inspection**: Regular maintenance and inspection of medical devices are essential to ensure continued electrical safety. This includes routine checks for damaged cables, worn insulation, and loose connections, as well as calibration of electrical components to maintain accuracy. 6. **User Training and Education**: Healthcare professionals must receive adequate training on the safe use and handling of medical devices, including understanding electrical safety precautions and protocols. This reduces the risk of accidents or errors caused by improper device operation. ### Challenges in Medical Device Electrical Safety: 1. **Technological Complexity**: Advancements in medical device technology introduce new challenges in ensuring electrical safety, especially with the integration of wireless communication, complex electronics, and connectivity features. 2. **Global Harmonization**: Harmonizing electrical safety standards across different regions and countries can be challenging due to varying regulatory requirements and interpretations. Manufacturers must navigate this complexity to ensure their devices can be marketed internationally. 3. **Emerging Risks**: With the rise of interconnected healthcare systems and IoT (Internet of Things) devices, there's an increased risk of cybersecurity threats and vulnerabilities that can impact electrical safety. Manufacturers must address these risks through robust cybersecurity measures. In conclusion, medical device electrical safety is a multifaceted aspect of healthcare technology that requires careful attention throughout the device lifecycle, from design and manufacturing to usage and maintenance. By adhering to stringent standards, conducting thorough risk assessments, and prioritizing user training, manufacturers can ensure the highest levels of electrical safety in medical devices, ultimately safeguarding patient well-being and healthcare outcomes. #medicaldevices #medicaldeviceregulation #medicalinnovation #medtech www.patintguard.com
The Electrical Safety of Medical Devices
To demonstrate that medical devices are safe, and their performance is ‘state of the art’ in line with their clinical intended use, medical device manufacturers must perform clinical evaluation. Clinical evaluation is a requirement of the Medical Device Regulation 2027/745 in the European Union and the UK medical device regulations 2002 in the United Kingdom. Clinical Evaluation forms part of the regulatory requirements that must be met before a manufacturer can apply the CE mark in the EU and the UKCA mark in the UK to their medical devices, and then place them on those markets. Clinical evaluation is a review of all the evidence that has been generated by the manufacturer, from verification and validation activities in the design and development phase and manufacturing phases, including, validation against harmonised standards used to demonstrate conformity, biological evaluation, software validation, sterility validation and so on, relevant to the medical device. It also encompasses a review of any clinical data pertinent to the medical device in the form of published clinical data on the device itself or on similar devices on the market, that can be used to indicate a devices performance and safety. It also reviews any non-published clinical studies or data generated by the manufacturer and assesses the risk management documentation generated by the manufacturer as well as the information provided to the user by the manufacturer, such as, instructions for use and labelling. The purpose of the clinical evaluation is to assess the device to see if the sum of the data generated to demonstrate safety and performance outweigh the risks of using the medical device. Clinical Evaluation is a continual process, for the lifetime of the medical device. The first stage of clinical evaluation is the clinical evaluation plan. The clinical evaluation plan establishes how a manufacturer will perform clinical evaluation. This includes how any scientific literature searches will take place and the methodology and research methods adopted to ensure that clinical data is being searched for follows a valid scientific method. The plan will set out the scope of the clinical evaluation and determine what type of data will be used to perform clinical evaluation. It will identify the relevant regulatory requirements that are applicable to the device in demonstrating performance and safety. Once the plan has been executed, the manufacturer must gather all the relevant pre-clinical data needed to support the clinical evaluation, clinical literature searches should take place using relevant clinical publication sources such as PUBMED and the Cochrane Library, or device/clinical area specific journals, or the unpublished results of clinical trials/studies that have been conducted on the medical device being evaluated. Medical device clinical evaluation should be carried out by suitably qualified experts on the subject device, this usually consists of a multidisciplinary team of experts with clinical knowledge, medical device specific knowledge from the design and manufacturing team, risk management team and regulatory and quality experts. Once all the data has been assessed and critically reviewed it should be presented in the form of a clinical evaluation report. The report should be a critical analysis of all the supporting pre-clinical and clinical data generated to support that the benefit of using the medical device out weighs the risks of using the medical device when considering its intended use. All medical device regardless of their classification must undergo clinical evaluation. For medical devices that are completely novel or legacy devices are being used within a new intended use for which there is no clinical history, it is usually expected that these devices undergo clinical trials to generate supporting clinical evidence that the intended use meets the state of the art. Once a device has been placed on the market, medical device manufactures need to update their Clinical Evaluation on an ongoing basis. This encompasses any new data that has been generated since the last clinical evaluation. Clinical Evaluation is expected to be performed at least on a 2 yearly basis or depending on the level of risk associated with the medical device. Data generated from Post Market Surveillance reports or Periodic Summary Reports should be included in the updated review, and information from Post Market Clinical Follow-up Reports. We hope you enjoyed this video. Please subscribe to our channel to keep up to date with the latest medical device and IVD related content. #medicalinnovation #medtech #medicaldeviceregulation #medicaldevices #euregulations #healthtech #medical www.patientguard.com
Clinical Evaluation of Medical Devices
We are on the cusp of a medical revolution, as important as (or perhaps even more than) the discovery of penicillin. With the advancement of Artificial Intelligence (AI) systems and the exponential increase in chip processing power, AI, has the power to revolutionise healthcare. AI is already being used in many healthcare medical devices, Diabetic Retinopathy Screening being just one. The systems have the power to personalise treatment and diagnose or prognose conditions years before they occur. In this video we will look at AI in medical devices and how regulation will need to be modified in order to keep control and monitor performance of AI technology within the medical device sector. #medicaldeviceregulation #medicalinnovation #healthcarecompliance #medicalinnovation www.patientguard.com
Regulating AI (Artificial Intelligence) Medical Devices
Are you grappling with the complexities of the In Vitro Diagnostic Regulation (IVDR) 2017/746? Identifying whether your product qualifies as an in vitro diagnostic (IVD) device under this regulation is crucial for compliance in the European market. In this insightful video, we unravel the intricacies of IVDR 2017/746 and provide practical guidance on how to ascertain if your product falls within the scope of IVD regulation. Join us as we explore the nuances of IVDR 2017/746, discussing key factors such as intended purpose, specimen type, and risk classification. Whether you're a manufacturer, importer, or distributor of IVD devices, this video equips you with the knowledge necessary to navigate regulatory requirements effectively. Stay ahead of the curve and ensure compliance with IVDR 2017/746. Watch our video now and empower your business with the insights needed to thrive in the ever-changing landscape of medical device regulation. Don't forget to subscribe to our channel for more updates on regulatory compliance, industry trends, and best practices for success in the IVD market. #IVDR #IVD #MedicalDevices #RegulatoryCompliance #EURegulations #Healthcare #MedicalTechnology #IVDClassification #MedicalDeviceRegulation #IVDR2017 #MedicalDeviceCompliance
Identifying if a product is an IVD under EU IVDR 2017/746
Are you uncertain about whether your product falls under the classification of a medical device in the European Union? Understanding the regulatory landscape can be daunting, but fear not – our comprehensive guide is here to help! In this enlightening YouTube video, we delve into the intricate world of EU regulations to answer the burning question: Is my product considered a medical device? Whether you're a seasoned entrepreneur or a newcomer to the market, grasping the nuances of medical device classification is essential for compliance and market access. Join us as we break down the criteria set forth by the EU Medical Device Regulation (MDR) to determine if your product fits the bill. From definitions and examples to practical insights, we'll provide clarity on the factors that influence classification decisions. Our expert analysis will equip you with the knowledge needed to navigate the regulatory maze confidently. Whether you're developing innovative healthcare technologies, diagnostic tools, or therapeutic devices, understanding the regulatory framework is paramount to ensuring safety, efficacy, and market success. Don't let uncertainty hold you back – empower yourself with the information you need to make informed decisions about your product's regulatory status in the EU. Tune in to our video and embark on the journey to compliance and market readiness today! #EUregulations #MedicalDeviceClassification #EuropeanUnion #Compliance #MarketAccess #EUMedicalDeviceRegulation #RegulatoryLandscape #HealthcareTechnologies #DiagnosticTools #TherapeuticDevices #Safety #Efficacy #MarketSuccess #RegulatoryFramework #ProductClassification www.patientguard.com
Navigating EU Regulations: Is My Product a Medical Device?
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