THE EUROPEAN MEDICAL DEVICE REGULATION GUIDEBOOK
Are you ready for the EU MDR?
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.
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
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.
Please note: Internet access is required to read all RAPS e-books. E-books cannot be downloaded for offline use.
RAPS Member: $175