top of page


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
15 views
0 comments


Roles in Quality System Management QMS- Efficient Management
The impacts of roles in quality system management that many managers overlook but can significantly slow down your organization. 1️⃣...
Nov 27, 2024
19 views
0 comments


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
20 views
0 comments


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
196 views
0 comments
bottom of page