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...

ColabON's Regulatory Change and Impact Analysis Accelerates and Improves Compliance Assessment Regulatory Change- and Impact Analysis...

International Standards Medical Devices Links and Tipps

SN EN ISO 13485/A11:2021 Medical devices — Quality management systems — Requirements for regulatory purposes Amendment 11 SN EN ISO...