Helping you on your regulatory journey with expert Medical Device Regulatory Consultancy.
Patient Guard provide professional Regulatory Affairs and Quality Assurance services through Medical Device and In-Vitro Diagnostics consultancy.
Trusted by leading organisations across the UK, US & Europe
As a leading medical device regulatory consultancy, Patient Guard operates and maintains a BSI-certified Quality Management System (QMS) compliant with ISO 13485. This certification reflects our absolute commitment to regulatory excellence, proving that we practice exactly what we preach. For medical device manufacturers, ensuring your compliance partners and suppliers operate within a rigorous quality framework is critical for mitigating risk. Click the button below to view and download our official ISO 13485 certificate.
Led by industry experts, Patient Guard delivers decades of hands-on experience in ISO 13485 quality management, EU MDR, and IVDR compliance. We go beyond generic checklists to act as a seamless extension of your engineering and quality assurance teams, providing the strategic support needed to navigate complex medical device regulations successfully.
As a Biomedical Scientist, David possesses a deep clinical and commercial understanding of the In Vitro Diagnostic (IVD) industry. He is a recognized expert in both UK and EU IVD regulatory affairs, providing strategic guidance on UKCA marking, CE-IVDR compliance, and complex regulatory submissions.
With over 20 years of experience in Medical Device Regulatory Affairs, David offers unparalleled expertise in both EU MDR and UK MDR compliance. As a former Higher Medical Device Specialist at the MHRA (Medicines and Healthcare products Regulatory Agency), he brings invaluable, insider insight into regulatory submissions, quality systems, and government enforcement.
With extensive experience in both EU and UK Cosmetic Regulations, Patient Guard specializes in authoring comprehensive Product Information Files (PIF) and Cosmetic Product Safety Reports (CPSR). Additionally, we provide expert guidance on Personal Protective Equipment (PPE) compliance, ensuring your products meet all essential safety and regulatory requirements for the UK and European markets.
With over 20 years of experience in toxicology, Steve offers specialized expertise in ISO 10993 biological evaluation and medical device biocompatibility testing. He provides strategic oversight for complex preclinical assessments, ensuring products meet the rigorous safety requirements demanded by global regulatory bodies.
Possessing a deep understanding of medical device risk management, we specialize in implementing and maintaining the rigorous requirements of ISO 14971. We guide manufacturers through the entire risk management lifecycle—from initial hazard identification and risk assessment to the creation of robust Risk Management Files necessary for global regulatory approval.
Possessing expert knowledge of Software as a Medical Device (SaMD) regulatory requirements, we specialize in guiding digital health innovators through the complexities of IEC 62304 and IEC 82304-1 compliance. From software lifecycle processes to standalone health software validation, we ensure your medical application meets the stringent safety and performance standards required for market clearance.
Alex possesses a deep, practical understanding of ISO 13485, having successfully designed, implemented, and maintained compliant Quality Management Systems (QMS) both internally for Patient Guard and for numerous global clients. Expert in bridging the gap between complex regulatory frameworks and daily operations, Alex ensures medical device manufacturers achieve and sustain seamless compliance.
Alex is a certified ISO/IEC 27001 Lead Auditor with extensive experience implementing and auditing Information Security Management Systems (ISMS). Specializing in data protection and cybersecurity compliance, Alex ensures that organizations establish robust information security frameworks to protect critical data and mitigate digital risks.
Alex possesses expert knowledge of FDA Medical Device Quality System Regulations (QSR), including 21 CFR Part 820 and the transitioned QMSR requirements. With a proven track record of successfully implementing and auditing US compliance frameworks for global clients, Alex ensures seamless market entry and robust FDA inspection readiness.
As a senior medical device expert, Eleanor brings over 10 years of specialized experience authoring compliant Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER). Deeply versed in the rigorous data requirements of EU MDR, she expertly guides manufacturers through literature reviews, clinical data appraisal, and lifecycle safety compliance to secure successful regulatory approval.
Holding a First-Class Honours degree in Biomedical Science, Eleanor leverages deep scientific expertise to deliver comprehensive Performance Evaluations for In Vitro Diagnostics (IVDs). Having worked extensively with major global corporations, she specializes in authoring compliant Performance Evaluation Plans (PEP) and Reports (PER) that meet the strict clinical evidence demands of IVDR compliance.
Eleanor’s exceptional analytical and research capabilities make her highly adept at conducting the rigorous scientific validation required for In Vitro Diagnostics (IVDs). She specializes in establishing robust scientific validity, analytical performance, and clinical performance data, ensuring complex diagnostic devices achieve total regulatory compliance.
In addition to managing operations at Patient Guard, Jackie spearheads our EU Authorised Representative (EC Rep) services, acting as the essential legal link for non-EU manufacturers. She also provides expert guidance on EUDAMED registration and data submission, ensuring clients navigate mandatory European medical device databases with absolute accuracy.
Leveraging Patient Guards deep compliance expertise, Jackie manages our UK Responsible Person (UKRP) services, with Patient Guard acting as the legally required representative for international manufacturers entering the Great British market. She expertly guides clients through the entire MHRA device registration process, ensuring swift, compliant access to the UK marketplace.
Jackie also supports our cosmetics industry clients by managing the mandatory notification processes for new products. She expertly handles submissions on both the UK Cosmetic Product Notification Portal (SCPN) and the European Cosmetic Products Notification Portal (CPNP), ensuring seamless, compliant market entry.
We provide a full range of industry-leading Medical Device Regulatory and Quality Services for a wide variety of medical device organisations across the UK, USA and Europe.
Internal auditing for medical devices plays a pivotal role in ensuring regulatory compliance, quality assurance, and patient safety within the healthcare industry.
We provide support in updating your technical including modifications or design updates to your device, revising and enhancing your risk management file, and ensuring your files are compliant.
Our clinical evaluation services are designed to support manufacturers in navigating the complex regulatory landscape, ensuring that their medical devices and IVDs meet the highest standards.
When it comes to launching your medical device in the US market, navigating the intricate landscape of FDA regulations is crucial.
Do you have a medical device or IVD idea? Are you a medical device start up? If so the prospect of medical device and IVD regulations can be daunting, especially if you have not done it before.
Once you have come up with the medical device or IVD concept, its time to start design and development.
Once the design has been finalised its time to transfer to manufacturing. This can be challenging and may require design changes to ensure that the device can be scaled.
Before you launch your medical device or IVD, it is important to ensure that you have met all of your regulatory obligations before placing product on the market.
Monitoring a medical device and IVD is important once it has been launched, to ensure that any unforeseen risks are captured and mitigated.
With over 20+ years of experience, we have not only amassed valuable insights but have also successfully guided lots of clients through the regulatory maze.
Recognising the unique nature of every Medical Device, our approach is highly customised. We meticulously tailor our services to meet the specific needs of your products and organisation, ensuring a personalised and effective regulatory strategy.
We offer comprehensive support that spans the entire product lifecycle. From initial consultations, to ongoing compliance management and even training courses, we are your dedicated partners.
We recognise the importance of time in the competitive landscape. Patient Guard prides itself on delivering timely and efficient services.
In choosing Patient Guard as your Medical Device Regulatory & Quality Assurance Partner, you’re not merely selecting a service provider; you’re opting for a dedicated partner committed to your success.
Patient Guard specializes in medical device and IVD (In-Vitro Diagnostic) regulatory consultancy. We provide expert support for CE Marking, UKCA marking, ISO 13485 Quality Management Systems (QMS) implementation, and FDA submissions to ensure your medical products meet global safety and performance standards.
We guide manufacturers through the entire technical documentation process. This includes creating and updating Technical Files, conducting Clinical Evaluations, and ensuring compliance with the latest EU MDR (2017/745) and IVDR (2017/746) regulations, as well as the UK Medical Device Regulations.
Yes. For non-UK manufacturers looking to sell in the United Kingdom, Patient Guard provides a designated UK Responsible Person service. We manage your MHRA registrations, maintain technical documentation, and act as your official liaison with UK regulatory authorities.
Our consultants provide end-to-end support for ISO 13485 implementation. This includes performing a gap analysis of your current systems, developing compliant QMS documentation, conducting internal audits, and providing full support during your Stage 1 and Stage 2 certification audits.
Absolutely. We help manufacturers establish robust Post-Market Surveillance plans and Vigilance reporting systems. Our team ensures that any adverse events are reported correctly to the relevant authorities and that your device’s safety and performance are monitored continuously after market launch.
Yes. We provide comprehensive Risk Management services in accordance with ISO 14971, ensuring that all potential hazards are identified and mitigated throughout the device lifecycle. Additionally, we author and update Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) to demonstrate the ongoing safety and clinical benefit of your products.
Patient Guard are an excellent source of medical regulatory compliance advice, we have taken advantage of their various services from their EU Rep service, to helping with technical files all the way through to using their ISO templates to implement our ISO 13485 system.”
Richard Crow, Blue Tree Group
Patient Guard have been a great support service to Cormed, providing help and advice promptly whenever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.”
Tracey Slater, Cormed
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I really appreciate the monthly news letter which summarises any changes/ news to regulations and standards.
This is very helpful to me and in addition, is considered a great service by our ISO13485 external auditor. They were very impressed when I showed them your monthly news letter at our latest audit.
We can clearly demonstrate that we are on top with the regulative requirements, as I read and check your news letter.”
Viktoria Kowal, Gallant
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