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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, 2025
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
EU-AI Act and Medical Devices: Compliance Assessment for Manufactures
EU AI Act and Medical Devices: The European regulation for artificial intelligence must also be applied to medical devices. With Prof....
Oct 25, 2024
Understanding SN EN ISO 13485/A11 2021 and its role in medical device compliance
SN EN ISO 13485/A11:2021 Medical devices — Quality management systems — Requirements for regulatory purposes Amendment 11 SN EN ISO...
Sep 30, 2024
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