Medical Device Regulatory & Quality Assurance Consultancy
Patient Guard is a Medical Device Quality & Regulatory consulting firm
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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

USA Medical Device

Europe Medical Device

Who We Work With

Our Clients

Bluetree Medical Devices
Origin Medical Devices
Peason Medical Devices
BuyDefinition Medical Devices
Orantech Medical Devices
NHS Liverpool University Hosptial Medical Devices
Stepper Eyewear

Get In Touch

Fill in the form below and our team will be happy to assist you