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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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How to optimize the process for Product Labeling for Medical Devices?
Product Labeling for Medical Devices is an essential part of the certification process and the technical documentation. It involves...
Nov 24, 2024
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How to generate a "List of Standards and Regulations" for Medical Devices: 3 Steps supporting registration and development
Strategy to select the essential standards and regulations supporting both, development and registration.
Nov 15, 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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