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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
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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
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Medical Devices and IVDs: Your Cookbook for the List of Applicable Standards, Regulations & Guidelines
International Standards Medical Devices Links and Tipps
Nov 9, 2024
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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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