Medical Device Regulatory & Quality Assurance Consultancy

Patient Guard is a Medical Device Quality & Regulatory consulting firm

PRRC - Person Responsible for Regulatory Compliance

PRRC- A monthly service membership to assist you with your regulatory compliance needs

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UKRP - UK Responsible Person and EUAR - EU Authorised Representative

Annual support with your EU and UK medical device registrations.

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Quality Support Services

A monthly service provided by our QA specialists, assisting you with maintaining and running your QMS.

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Biological Evaluation Report, EU CE and UKCA Mark Technical Files

Expert reports written by our Regulatory Affairs team for UKCA and CE Mark compliance.

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Medical Device Consultancy

It might be difficult to get a product on the market. We are professionals who regularly deliver the outcomes you require.

CE/UKCA Mark Technical Files

Patient Guard can assist you in ensuring that your Technical Files are in compliance with the UK regulations for the purposes of UKCA marking.

Quality Management System

Patient Guard has extensive expertise in developing quality systems, and we will do it in the format that is most convenient for you.

What We do

Assisting you in being compliant

We provide a wide range of high-quality services, such as regulatory consultancy for medical devices and IVDs, and consulting and advice around medical device and IVD compliance. We provide full document generation services such as compliant Technical files, as well as UK Responisble Person Services and EU Authorised Representative Services. We can work with a flexible approach such as a block of time dedicated to helping you or tailored monthly services on retention to help with the cost burden on your business. We can make a service that works for you and your business.

What we do

Our Services

UK Medical Device
Services

USA Medical Device
Services

Europe Medical Device
Services

Who We Work With

Our Clients

"We found Patient Guard via a simple internet search and are delighted we did!

They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble.

We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories.

Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the main areas of their service for us."

“Patient Guard has helped Blue Tree Group from start to finish on our medical device development journey, they have helped us navigate the complexities of both EU and UK regulation requirements. We would recommend Patient Guard to any medical device manufacturers looking for regulatory support.”

“Very friendly and knowledgeable team who makes an effort to help with anything from understanding complex regulations to practical advice. I would say: Give them a call. Patient Guard are clear in how their services can be of help to your company.”