Developing
& maintaining
an IVD quality management
system

A guide to QMS scope, risk management, performance evaluation, post-market surveillance, IVDD to IVDR transition and more.

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Does your Quality Management System comply with the new IVD requirements?

 

Learn more in this whitepaper...

There are many different requirements with which in vitro diagnostic manufacturers must comply in order to place product on the market. At the core of most of these requirements is a fundamental need to have a good quality management system (QMS) in place. This paper primarily examines the QMS requirements in the new In Vitro Diagnostic Device Regulation (IVDR) 2017/7462 which has entered into force as of 26 May 2017 and will serve as the basis for access to the European market. Complying with these requirements will largely fulfil those requirements established in ISO 13485:2016 (Medical devices – quality management systems – requirements for regulatory purposes).