About Patient Guard
A Leading Medical Device Consultancy Established in 2017 with Global Expertise in Regulatory Affairs and Quality Assurance
Our Mission
Patient Guard is dedicated to offering professional Regulatory Affairs and Quality Assurance services in the Medical Device and In Vitro Diagnostics (IVD) industry. Through our innovative approach, level-headed customer service, and technical expertise, we ensure client satisfaction.
Our consultants and team excel at clear communication, delivering services in a well-organized, concise manner. We prioritize creating precise technical documents, ensuring compliance with regulations in both the UK , EU , and USA. With a focus on transparency, friendliness, and support, Patient Guard aids clients in navigating complex Medical Device and IVD regulations.
Our commitment extends to providing straightforward advice, cutting through regulatory jargon to offer easily understandable guidance. We’re here to simplify the complexities, making compliance accessible and comprehensible for our clients.
Our Values
Clear:
Communicating clear advice and guidance to our customers, holding their hands throughout the process from start to finish. Making sure our customers understand the type of information they need to generate to become compliant.
Concise:
Giving brief and comprehensive information, enabling customers to understand their responsibilities around medical device regulation and quality assurance. Removing the jargon and complexity to deliver projects that are value for money and nurture customer relationships.
Precise:
Being exact, accurate and careful at all times, so we deliver professional documentation to our customers.
Our History
Founded in 2017 by David Small, as seen in the image above, Patient Guard boasts a rich history in the medical device realm. Initially a Biomedical Scientist in the NHS post his Biomedical Science Degree, David furthered his expertise with an MSc in Analytical Bioscience and Drug Design.
Later, he transitioned to the MHRA, serving as a medical device specialist and, eventually, a higher medical device specialist. This experience paved the way for roles in various sectors: Quality Assurance, Regulatory Affairs, and Medical Device Design and Development, culminating in the establishment of Patient Guard Limited.
In the six years that followed, Patient Guard has soared, evolving into one of the UK’s premier Medical Device Consultancies. 2021 marked a significant milestone, with the inception of Patient Guard Europe UG in Germany. This strategic move broadened the scope, enabling the Patient Guard Group to offer comprehensive Quality Assurance and Regulatory Affairs services, both in the UK and across the EU.
Since this expansion, Patient Guard’s impact has been profound, extending support to numerous Medical Device Manufacturers and Developers. Their reach spans diverse entities: from dynamic Start-ups and SMEs to esteemed Government Agencies, the NHS, and multinational corporations.
Tracey Slater, Cormed
Some of Our Clients
News from Patient Guard
Understanding Your Obligations Under MDR/IVDR
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), compliance isn’t just the manufacturer’s responsibility. Importers,
Post‑Market Surveillance Lessons from Real‑World Audits
Post-Market Surveillance (PMS) is one of the most underestimated areas of medical device compliance — yet it’s also one of
Why ISO 13485 is More Than a Checkbox
When medical device manufacturers hear about ISO 13485 certification, it’s often described as a requirement — a hurdle to market
Building a Strong MDR Technical File: Avoid Pitfalls and Prepare for Notified Body Audits
Under the EU Medical Device Regulation (MDR) 2017/745, your technical file is not just a collection of documents—it’s the complete
