Helping medical device, IVD and software manufacturers navigate complex regulations with practical regulatory expertise, ISO 13485-certified quality systems and tailored compliance support.
Patient Guard supports medical device, IVD, software, healthcare and life science organisations across the UK, Europe and international markets.
Practical regulatory and quality support from a specialist medical device consultancy trusted by manufacturers across the UK, EU and international markets.
Benefit from practical regulatory insight shaped by experience of UK medical device regulatory expectations.
We operate our own certified quality management system, demonstrating the same high standards we help our clients implement.
Supporting manufacturers through UK Responsible Person, EU Authorised Representative and international regulatory consultancy services.
Trusted by startups, SMEs and multinational medical device manufacturers since 2017.
Our Quality Management System is independently certified by the British Standards Institution (BSI) to ISO 13485:2016, demonstrating that we operate to the same internationally recognised quality standards that we help our clients achieve.
For medical device manufacturers, selecting a consultancy that operates under an independently audited quality management system provides additional confidence that your regulatory partner follows robust, documented and controlled processes.
View Our BSI ISO 13485 Certificate
Our experienced regulatory, quality and clinical specialists become an extension of your team, helping you navigate medical device compliance with confidence.
A complete range of regulatory, quality and compliance services to help medical device, IVD, software and digital health manufacturers achieve and maintain market access.
Strategic regulatory support for manufacturers navigating UK, EU and international medical device requirements.
Learn more ->Preparation and review of technical files for CE marking, UKCA marking and regulatory submissions.
Learn more ->Clinical evaluation plans, clinical evaluation reports and lifecycle clinical evidence support under EU MDR.
Learn more ->ISO 10993 biological evaluation support, including biocompatibility strategy and evidence reviews.
Learn more ->Quality management system implementation, improvement and audit support for medical device organisations.
Learn more ->Information security management system support for organisations implementing ISO 27001 and improving cyber security governance.
Learn more ->EU Authorised Representative services for non-EU medical device manufacturers placing devices on the EU market.
Learn more ->UK Responsible Person support for overseas manufacturers registering and maintaining devices in Great Britain.
Learn more ->Whether you are developing a new device, preparing for launch or maintaining compliance after market entry, Patient Guard can support you at every stage of the medical device and IVD regulatory lifecycle.
Early-stage regulatory advice to help you understand classification, intended purpose, route to market and key compliance requirements.
Speak to us →Support with design controls, risk management, usability, software lifecycle planning and technical documentation strategy.
Speak to us →Quality management, supplier controls, validation planning and regulatory evidence to support compliant manufacturing.
Speak to us →Final technical file preparation, UKCA or CE marking support, registrations and market access readiness.
Speak to us →Post-market surveillance, vigilance, PMS reports, PMCF or PMPF activities and ongoing regulatory compliance support.
Speak to us →Support with product changes, discontinuation planning, legacy device compliance and lifecycle management.
Speak to us →Whether you need regulatory strategy, technical documentation, quality management support or market representation, Patient Guard can help you achieve compliance with confidence.
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
Understanding how your in vitro diagnostic device is classified under the EU IVDR is one of the first and most important steps towards regulatory compliance. This guide explains the IVDR classification rules, the differences between Class A, B, C and D IVDs, how Annex VIII is applied, and how classification
A material change, supplier switch, manufacturing transfer or design modification does not automatically require new ISO 10993 biocompatibility testing. Learn how manufacturers use Biological Evaluation Plans (BEPs), chemical characterisation, toxicological risk assessments and Biological Evaluation Reports (BERs) to determine whether existing biological evidence remains valid or whether additional testing is
More than half of IVDR submissions face deficiencies during Notified Body review, with Performance Evaluation Reports (PERs) among the most common areas of concern. Learn the three critical mistakes that lead to PER rejections—including weak State of the Art justification, non-systematic literature reviews, and poor traceability between Scientific Validity, Analytical
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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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