The European In Vitro Diagnostic Regulation

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RAPS has teamed up again with Meddev Solutions to offer a practical guide to implementing the EU IVDR. Focusing on the new European regulation and how to apply the requirements into your business, the guidebook provides tools such as QMS checklists, performance evaluation checklists and other useful information to help you understand what is required. Designed as a reference guide, the book is broken into sections that can be quickly navigated through, giving reference to the original EU IVDR text and what requirements must be met. It does not replace the EU IVDR text, which should be used in conjunction with this guidebook.

Who Should Buy this Book?

This guidebook was developed for anybody needing to understand what the EU IVDR may mean to them and is primarily focused on manufacturers of in vitro diagnostic devices.

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