#QMS

Current List of Harmonized Standards under the EU-IVDR (In Vitro Diagnostic Devices)

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

Nov 12

quality management system iso 13485 optimization

How to Optimize a Quality Management System ISO 13485 that includes Regulatory-Critical Processes?

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

Feb 18

What is a Regulatory Change- and Impact Analysis?

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

Feb 17

ColabON's Roles and Responsibility for Quality Management System are designed for organizational changes. They are a content element, than can be used in processes. This helps not only for re-organizations, but also to understand trainings needs.

How to define Roles and Responsibility for Quality Management System: Once and for all

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

Nov 27, 2024

Current List of Harmonized Standards under the EU-IVDR (In Vitro Diagnostic Devices)

How to Optimize a Quality Management System ISO 13485 that includes Regulatory-Critical Processes?

What is a Regulatory Change- and Impact Analysis?

How to define Roles and Responsibility for Quality Management System: Once and for all

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