THE EUROPEAN IN VITRO
DIAGNOSTIC DEVICE REGULATION GUIDEBOOK
Available September 1st
This European In Vitro Diagnostic Device Regulation Guidebook, is a comprehensive reference resource for In Vitro Diagnostic Device manufacturers operating or selling devices in the EU.
It distils the IVDR into meaningful chapters with a host of tools that can be used to assist in complying with the requirements of the IVDR.
TAKE A LOOK INSIDE
This guidebook is all about the brand new European regulation and how to apply the requirements into your business.
This is part of the Meddev Solutions Guidebook Series, which provides practical tools and guidance for In Vitro Diagnostic Device manufacturers and anyone else with a need to understand exactly how to implement the IVDR.
This book is a reference guide, and as such, is not designed to be read from cover to cover. It is broken into sections that can be quickly navigated through, giving reference to the original IVDR text, and what requirements must be met. However, it does not replace the IVDR text, which should be used in conjunction with this guidebook.
The Meddev Solutions’ Guidebook Series offers practical application guidance to a number of topics that are important for device manufacturers to understand.
Discover the EU MDR Guidebook here.
We have teamed up with the Regulatory Affairs Professionals Society (RAPS) to offer our IVDR book in a convenient e-Book format.
This IVDR e-Book provides the exact same comprehensive analysis in 376 pages on how to apply the IVDR 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