Patient Guard

About Patient Guard

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

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.

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

Our team

David Small - Founder / CEO

Image of our founder David Small he is the CEO of Patient Guard Group

David is a Biomedical Scientist by background and has worked for the NHS and at the MHRA as a Higher Medical Device Specialist, as well as  the Medical Device industry in Medical Device Quality and Regulatory Roles. David has degrees in Biomedical Science (BSc Hons) and Analytical Bioscience & Drug Design (MSc). David is also a member of TOPRA and the British Toxicological Society. 

Steve Condie - Regulatory Manager

Patient Guards Regulatory Affairs Manager

Steve has worked in toxicology for over 20 years being the section head of Medical Devices and Toxicology at a Medical Device and Pharmaceutical test house. Steve was involved in the management of GLP and GMP requirements for the facility as well as a home office licence holder. Steve is well versed in the requirements needed for ISO 10993 medical device Biological Evaluation. Steve is a member of TOPRA.

Alex Lewis - Quality Assurance Manager

Alex Lewis - Patient Guards Quality Assurance Manager

Alex Lewis has a background in Biomedical Science, after graduating with a BSc in Biomedical Science, Alex went on to become a Laboratory Technician at UCLAN where he became involved in helping to develop procedures and Quality Assurance related documentation. Alex has been trained in ISO 9001 and ISO 13485, as well as internal auditor training. Since joining Patient Guard Alex has gone on to become the Quality Assurance Manager after successfully implementing ISO 13485 QMS’ for customers who have gone on to gain ISO 13485 certification from Notified Bodies.  

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