Medical Device Technical Checklist

This EU Medical Device Regulation (MDR) 2017/745 checklist is a great tool to enable you to ensure you meet all the document compliance requirements of Annex II and Annex III for your medical device.

Trusted by leading medical device organisations across Europe

Liverpool University Hospitals NHS Foundation Trust
Orantech
Cormed
Pearson

EU Medical Device Regulation (MDR) 2017/745 checklist

Our checklist includes helpful instructions and signposting as to what information should go where within your technical file. It covers all types of medical devices so its important to identify what sections will be applicable to your medical device.

patient guard

Lorem Title

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. 

patient guard

Patient Guard are an excellent source of medical regulatory compliance advice, we have taken advantage of their various services from their EU Rep service, to helping with technical files all the way through to using their ISO templates to implement our ISO 13485 system.”

Richard Crow

patient guard

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

Why Organisations Choose Patient Guard

Expertise &
Experience

With over 20+ years of experience, we have not only amassed valuable insights but have also successfully guided lots of clients through the regulatory maze.

Tailored
Solutions

Recognising the unique nature of every Medical Device, our approach is highly customised. We meticulously tailor our services to meet the specific needs of your products and organisation, ensuring a personalised and effective regulatory strategy.

End-to-End
Support

We offer comprehensive support that spans the entire product lifecycle. From initial consultations, to ongoing compliance management and even training courses, we are your dedicated partners.

Timely
& Efficient

We recognise the importance of time in the competitive landscape. Patient Guard prides itself on delivering timely and efficient services.

Committed
Partners

In choosing Patient Guard as your Medical Device Regulatory & Quality Assurance Partner, you’re not merely selecting a service provider; you’re opting for a dedicated partner committed to your success.

Get in touch

For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
Patient Guard Medical Device and IVD Regulatory and Quality Assurance consultancy
UK Office

Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP

German Office

Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen, 
Deutschland / Germany

Copyright © Patient Guard | Website design and marketing by Sharp Ahead

Speak to one of our medical device consultants

For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.

UK Office

Get the Medical Device Technical Checklist

Complete the form below and receive instant access.

Get the Medical Device Technical Checklist

Thank you! The checklist is now ready to download.

Get the latest updates on medical device regulation

Sign up to our newsletter and we’ll deliver news and insights straight to your inbox.

Patient Guard Regulatory Affairs and Quality Assurance

Do you need support with Medical Device or IVD compliance?

We can help you!