The EU MDR Guidebook

Version 2 is coming soon! Join the waiting list to get your hands on the next version of the must have guide for MDR implementation.

Guidebook Content 

 

▪  Background to the MDR

▪  Compliance guide 

▪  Process table

▪  Maps (Annexes, Clinical, PMCF, PMS, Vigilance & NB's)

▪  QMS tables 

▪  SPR & Risk checklists

▪  Timelines 

▪  MDR Overview - Articles (1 - 123)

▪  MDR Overview - Annexes 

▪  People in the MDR

▪  Player roles 

Pages

380

Chapters

13

Price

£225 

Sorry, all sold out! Join our waiting list for the next release here.

If you are involved in ensuring compliance with the EU MDR, the Meddev Solutions MDR Guidebook will be your ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again.

 

This Guidebook is a reference guide and as such, is not designed to be read cover to cover. It is broken into sections that can be quickly referenced to help navigate through the text of the MDR and to implement the requirements needed. 

 

It contains a number of useful tools and tables to guide you through the MDR, such as:

​- Device classification and their differences from the MDD
- QMS requirements and how they align with ISO 13485
- Technical documentation requirements
- Clinical data requirements, including a handy checklist
- General safety and performance requirements tables
- Annex and article guide

This book is part of the Meddev Solutions’ Guidebook Series, offering practical application guidance to a number of topics that are important for device manufacturers to understand.

Discover the EU IVDR Guidebook here. 

RAPS MDR eBook

We have teamed up with the Regulatory Affairs Professionals Society (RAPS) to offer our MDR book in a convenient e-Book format.

This MDR e-Book provides the exact same comprehensive analysis in 380 pages on how to apply the MDR requirements to your business.

Sorry, all sold out! Join our waiting list for the next release here.

Looking for EU MDR training courses? 

Join our mailing list for 10% off the MDR Guidebook

Address

Meddev Solutions Ltd

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Email: info@meddevsolutions.co.uk

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