Our Services
Medical Device, IVD, Cosmetic, PPE regulatory and quality Services from Patient Guard are industry leading.
Patient Guard has developed into one of the leading regulatory consultancies, trading since 2017.
An established regulatory and quality assurance consultancy providing a comprehensive, single-source solution for your compliance requirements.
Our medical device, IVD, digital health, cosmetic and PPE compliance services are tailored to your organisation, products and target markets. We provide clear strategic direction and practical guidance throughout the product lifecycle, helping you manage regulatory risk, maintain compliance and bring products to market with confidence.
Medical Devices
Medical Device Consultancy
Strategic compliance support guiding medical device and IVD organisations through complex international frameworks. We provide professional assistance across product development, risk assessment and regulatory submissions from concept to market access.
CE Marking Technical Files (EU MDR)
Expert creation and remediation of Technical Documentation required for EU CE marking. We systematically review clinical evidence, risk management and General Safety and Performance Requirements to align files with EU MDR and Notified Body expectations.
UKCA Mark Technical Files
Prepare Technical Documentation structured to support medical device market access in Great Britain. We review labelling, risk management, clinical evidence and supporting records against the UK Medical Devices Regulations 2002.
FDA 510(k) Submissions
Expert guidance through the US 510(k) clearance process. We support predicate device selection, substantial equivalence strategy, evidence planning and the preparation of structured submissions for FDA review.
FDA Pre-Submissions
Reduce uncertainty by seeking formal FDA feedback before completing product development or preparing a regulatory submission. We help define key questions and prepare structured Pre-Submission documentation.
Medical Device UK Responsible Person
Regulatory representation for manufacturers based outside the UK placing medical devices on the Great Britain market. We support MHRA registration, maintain access to documentation and act as your regulatory liaison.
Medical Device EU Authorised Representative
European market representation through Patient Guard Europe UG in Germany. We fulfil the responsibilities of an EU Authorised Representative under the MDR and IVDR and support EUDAMED and competent authority communications.
Person Responsible for Regulatory Compliance (PRRC)
Outsourced PRRC support for eligible manufacturers and Authorised Representatives under the EU MDR and IVDR. We provide independent regulatory oversight across Technical Documentation, QMS, post-market and vigilance obligations.
Clinical Evaluation
Clinical Evaluation Plans and Reports prepared and maintained in accordance with EU MDR requirements. We systematically identify, appraise and analyse clinical evidence throughout the medical device lifecycle.
Post-Market Surveillance (PMS)
Establish and maintain effective post-market systems for gathering, reviewing and acting on information about device quality, performance and safety after market placement.
Post-Market Clinical Follow-up (PMCF)
Develop proportionate PMCF Plans and Evaluation Reports to proactively gather clinical data, confirm continued safety and performance, and identify emerging risks throughout the device lifecycle.
Biological Evaluation
Biological Evaluation Plans and Reports developed in accordance with ISO 10993. We assess materials, manufacturing processes, patient contact and available evidence to establish a proportionate biocompatibility strategy.
ISO 14971 Risk Management
Develop and maintain lifecycle risk management documentation aligned with ISO 14971, including hazard identification, risk evaluation, control measures, benefit-risk analysis and post-production review.
In Vitro Diagnostics (IVDs)
IVD CE Marking Technical Files (EU IVDR)
Professional preparation and remediation of IVD Technical Documentation under the EU IVDR, including performance evidence, risk management, labelling and General Safety and Performance Requirements.
IVD UKCA Mark Technical Files
Structured Technical Documentation support for in vitro diagnostic devices intended for the Great Britain market. We align performance, safety and quality evidence with applicable UK requirements.
IVD UK Responsible Person
UK regulatory representation for overseas IVD manufacturers placing devices on the Great Britain market. We support MHRA registration and act as your local regulatory contact.
IVD EU Authorised Representative
European representation for non-EU IVD manufacturers through Patient Guard Europe UG. We support IVDR compliance, EUDAMED obligations and communications with competent authorities.
Performance Evaluation (EU IVDR)
Develop Performance Evaluation Plans and Reports integrating scientific validity, analytical performance and clinical performance evidence in accordance with EU IVDR requirements.
Scientific Validity Reports (EU IVDR)
Systematic scientific literature reviews demonstrating the association between an analyte or marker and the relevant clinical condition or physiological state.
Post-Market Performance Follow-up (PMPF)
Develop PMPF Plans and Evaluation Reports to proactively confirm continued IVD performance, identify emerging risks and maintain the performance evaluation throughout the product lifecycle.
Post-Market Surveillance for IVD Manufacturers
Establish ongoing processes for monitoring IVD quality, safety and performance, including PMS Plans, PMS Reports, Periodic Safety Update Reports and vigilance support.
Quality Assurance
ISO 13485 QMS Implementation
End-to-end support to implement an ISO 13485 Quality Management System tailored to your organisation. We assist with gap assessment, documentation, process implementation and preparation for certification audits.
ISO 13485 Internal Auditing Service
Independent internal audits to assess QMS effectiveness, identify nonconformities and prepare your organisation for certification, surveillance or regulatory inspections.
ISO 9001 Implementation
Develop a practical ISO 9001 Quality Management System designed around your organisation's processes, objectives and operational needs, from initial gap assessment to certification readiness.
ISO 9001 Internal Auditing Service
Independent process audits to assess the effectiveness of your ISO 9001 QMS, identify improvement opportunities and prepare your organisation for external surveillance or recertification audits.
ISO/IEC 27001 Implementation
Implement a structured Information Security Management System to manage information security risks, safeguard sensitive data and demonstrate effective governance to customers and procurement teams.
ISO/IEC 27001 Internal Auditing Service
Independent auditing of your Information Security Management System to identify compliance gaps, assess control effectiveness and support certification or surveillance audit preparation.
FDA Quality Management System Implementation
Quality system implementation support for medical device manufacturers entering the US market, helping align operational processes and documentation with applicable FDA requirements.
FDA Quality System Internal Auditing
Independent quality system audits designed to identify compliance gaps, verify implementation and prepare your organisation for FDA inspections and regulatory review.
Digital Health Services
DTAC Readiness Assessment
Understand your current position against the NHS Digital Technology Assessment Criteria. We assess available documentation and evidence, identify compliance gaps and provide a prioritised roadmap towards DTAC readiness.
DTAC Accelerator Services
Hands-on implementation support to help your organisation address identified DTAC gaps. We develop and improve the policies, procedures, documentation and evidence required across the applicable DTAC domains.
Clinical Safety Compliance Services
Specialist support for clinical risk management and compliance with DCB0129 and DCB0160, including hazard identification, Hazard Logs, Clinical Safety Case Reports and supporting safety documentation.
NHS Procurement Ready
A comprehensive readiness programme bringing together DTAC, clinical safety, regulatory compliance, information governance, cyber security, quality management and procurement evidence to support NHS market access.
Compliance Essentials
Flexible monthly support for digital health organisations requiring ongoing DTAC, clinical safety, information governance, cyber security and NHS procurement compliance guidance.
Cosmetics Services
Cosmetic Product Safety Reports (CPSR)
Professional cosmetic safety assessments reviewing formulation, ingredients, exposure and available toxicological data to demonstrate product safety under UK and EU cosmetics legislation.
Cosmetics Product Information Files (PIF)
Compile and maintain structured Product Information Files containing the safety, manufacturing, claims and supporting evidence required for UK and EU cosmetic product compliance.
UK Cosmetics Responsible Person
UK Responsible Person services for cosmetic brands placing products on the Great Britain market, including compliance review, Product Information File maintenance and SCPN notification support.
EU Cosmetics Responsible Person
EU Responsible Person support for cosmetic manufacturers placing products on the European market, including compliance review, Product Information File maintenance and CPNP notification support.
PPE Services
UK PPE Authorised Representative
UK regulatory representation for overseas PPE manufacturers placing products on the Great Britain market. We review compliance documentation and act as your local regulatory contact.
EU PPE Responsible Person
European market support for PPE manufacturers requiring an economic operator within the EU. We review compliance records and help maintain documentation for competent authority requests.
