This overview presents the currently harmonized and relevant standards for in vitro diagnostic devices (IVDs) under the European Regulation (EU) 2017/746 (IVDR). Harmonized standards bridge the gap between legal requirements and technical implementation. They help demonstrate the state of the art  and simplify the process of proving conformity with the IVDR. All official Publications of EU-IVDR Harmonized Standards for invitro diagnostic devices (IVDs) Current Status: 08.04.2

A quality management system (QMS) compliant with ISO 13485 is mandatory for manufacturers of medical devices and IVDs. Without ISO 13485...

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EU AI Act and Medical Devices:  The European regulation for artificial intelligence must also be applied to medical devices. With Prof....

In the medical device industry, balancing compliance costs  with the need for speed and innovation is a constant challenge. How does your...