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quality management system iso 13485 optimization

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

Change History: MDR Medical Device Regulation EU 2017/745

Change History: MDR Medical Device Regulation EU 2017/745

Change History: MDR Medical Device Regulation EU 2017/745

Overview of the current changes to the Medical Device Regulation (MDR). We collected all helpful data within the ColabON tool. This involved

Jan 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.

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

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