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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
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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
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Success Through Reliable Information: Standards and Regulations for Medical Devices - 3 Success Factors
Standards and Regulations for Medical Devices: Not Obstacles, but the Key to Success, Innovation, and Trust Standards and regulations in...
Nov 15, 2024
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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 What is the...
Sep 30, 2024
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3 Tips to Win the Never-Ending Battle of Keeping Up: How to Manage Changing Regulatory Requirements for Medical Devices
In the highly regulated world of medical devices, staying compliant with ever-evolving regulatory requirements is critical for...
Sep 6, 2024
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The Hidden Risks of Poor Data Quality: Low Degree of Digitization in Medical Device Industry
Poor Data Quality lead to High time loss for experts in norm interpretation Very high costs for maintaining traceability High compliance...
Aug 16, 2024
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