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5 days ago
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
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Nov 27, 2024
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...
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Nov 15, 2024
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...
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Nov 9, 2024
Most Important Links to Regulations and International Standards Medical Devices
International Standards Medical Devices Links and Tipps
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Sep 30, 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 What is the...
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Sep 6, 2024
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...
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Aug 16, 2024
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...
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