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...

Roles and Responsibility: A role is a function of a person.

Product Labeling for Medical Devices is an essential part of the certification process and the technical documentation. It involves process requirements for product development and product requirements. Why is Product Labeling for Medical Devices an important aspect? Product Labeling for Medical Device is a critical aspect of medical device development and regulatory compliance. A clear, accurate, and comprehensive label is essential for: Patient safety:  Ensuring safe use by

Strategy to select the essential standards and regulations supporting both, development and registration.

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

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