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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.

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

Some of Our Clients

Meet the Team

David Small - Founder/CEO

David has a degree in Biomedical Science and a master’s degree in Analytical Bioscience and Drug Design; David has previously worked at the MHRA as a higher medical device specialist and within the medical device industry before setting up Patient Guard in 2017. David has over 20 years’ experience in medical devices

Steve Condie - Regulatory Manager

Steve has over 20 years working in Toxicology having previously worked at microbiological and toxicological test houses, Steve has worked at Patient Guard for over 4 years and brings a wealth of experience in assessing medical devices against ISO 10993

Alex Lewis - Quality Assurance Manager

Alex Lewis is a lead auditor and has a degree in Biomedical Science, an experienced and well qualified Quality Assurance professional with expertise in the implementation of ISO 13485 Quality Management Systems and IEC 27001 Information Management Systems

Eleanor Shackleton - Clinical & Regulatory Specialist

Eleanor is the newest addition to our team, bringing with her a wealth of clinical and regulatory expertise. Eleanor has a degree in Biomedical Science and has over 10 years’ experience working in the medical device and IVD industry, with specific emphasis in Clinical Evaluation of Medical Devices and Performance Evaluation of IVDs