Expert regulatory affairs and quality assurance consultancy supporting manufacturers through the entire device lifecycle—from classification and clinical evaluation to market access.
Medical device manufacturers must navigate complex regulatory requirements to bring products to market and maintain compliance across multiple jurisdictions.
From EU MDR and UKCA marking to FDA requirements and ISO standards, ensuring compliance can be resource-intensive and technically challenging.
Patient Guard provides expert medical device consultancy services, supporting organisations with regulatory strategy, quality management systems, technical documentation, and ongoing compliance.
We work as an extension of your team, providing practical, hands-on support tailored to your products and business goals.
Whether you are developing a new device, entering a new market, or addressing regulatory challenges, we provide a structured and reliable pathway to compliance.
Our team consists of highly experienced regulatory affairs and quality assurance professionals dedicated to simplifying compliance frameworks.
We don't believe in unnecessary administrative bloat. We build practical, efficient systems designed to fit your unique business operations.
From UKCA and CE Marking to FDA submissions, we provide comprehensive strategic pathways to launch your devices in global markets.
Since 2017, hundreds of global medical device and IVD manufacturers have trusted us to secure and maintain their compliance status.
We work as an extension of your team, actively authoring documentation and supporting you all the way through to successful audit completion.
We balance business agility with strict regulatory safety requirements, providing compliance strategies tailored entirely to your device's risk tier.
Our consultancy team is comprised of experienced regulatory professionals with backgrounds in biomedical science, quality assurance, and clinical affairs. We operate out of registered offices in the UK and Germany, offering local compliance capability across Europe and Great Britain. Patient Guard operates under a BSI-certified ISO 13485 Quality Management System.
Developing robust, defined routes to market for UKCA (MHRA), CE Marking (MDR/IVDR), and international global registrations.
Designing, implementing, and maintaining fully compliant QMS frameworks tailored precisely to EN ISO 13485, ISO 9001, and ISO 27001 standards.
Authoring and updating technical documentation to ensure absolute alignment with rigorous Notified Body and regulatory expectations.
Compiling comprehensive Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) utilizing solid evidence streams.
Establishing comprehensive risk files under EN ISO 14971, linking product hazards seamlessly with your active safety and design data.
Setting up proactive PMS loops, PMCF/PMPF plans, and trend tracking architectures to successfully maintain long-term compliance lifecycle safety.
| Stage | What Patient Gauard Does |
|---|---|
| Concept & Classification | Determine the correct risk class (Class I, IIa, IIb, III) for your device. |
| Verification & Validation | Advise on testing, biocompatibility, and software validation (SaMD). |
| Market Launch | Register with the MHRA, appoint a UK Responsible Person, or access EU markets. |
| Post-Market Surveillance | Set up PMS, vigilance reporting, and PSUR writing to maintain compliance. |
We provide consultancy across key global regulatory frameworks, including:
We assess your product, regulatory requirements, and current status.
We identify compliance gaps and define a clear action plan.
We support documentation, systems, and regulatory activities.
We ensure your systems and documentation meet regulatory requirements.
We provide continued support for audits, inspections, and updates.
We provide consultancy across all key regulatory and quality areas, including:
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£150 per hour with no hidden fees. Work directly with experienced regulatory consultants and only pay for the time used. Ideal for quick advice, gap assessments, or ongoing project support.
We discuss your requirements, challenges, and define the scope of support needed.
We begin providing guidance, identify key gaps, and outline clear next steps.
Continued consultancy support tailored to your project timeline, priorities, and regulatory needs.
A medical device consultant supports manufacturers with regulatory compliance, quality systems, and documentation required to bring and maintain products on the market.
Ideally at the early stages of product development, but consultancy support can be provided at any stage of the lifecycle.
Yes, we regularly support start-ups with regulatory strategy, CE marking, and QMS implementation.
Yes, we support EU, UK, and US regulatory frameworks.
Support can typically begin within a few days depending on project scope.
Click on the links below to discover more:
Explore medical device regulatory consulting services for ISO, FDA, EU, and more. Build compliant systems, pass audits, and scale globally with expert support.
A milestone that strengthens our commitment to quality
Regulatory and quality consulting is one thing. Building, implementing, and passing audits on your own Quality Management System is another.
UDI medical devices are not just a labelling requirement. They are the backbone of traceability under EU MDR.
EUDAMED enters a new phase as four modules become mandatory from 28 May 2026. Learn what changes and how to prepare for compliance.
Medical devices exist to improve health outcomes, but every device carries potential risk. Managing those risks in a structured, documented, and defensible way is essential for regulatory approval and patient safety.
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.
UK Office
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
Thank you! The checklist is now ready to download.
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
