TAKE A LOOK INSIDE
The Meddev Solutions MDR book is all about the brand new European regulation and how to apply the requirements to your business.
This MDR book 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.
As seen in the MedTech Strategist magazine.
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.