Patient Guard

About Patient Guard

Picture of the patient guard team when they had mental health first aid training

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 UKEU , 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.

An image with a upward trend graph. On each upward line of the graph it says "make things better" - Patient Guard uses this image to represent its medical device, IVD Quality Assurance and Regulatory Affairs consultancy services.

Our Values


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.


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.


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.

Photograph of medical devices including blood glucose meters, injector pens and IVD test strips

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Do you need support with Medical Device or IVD compliance?

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