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 24
Optimizing Your Medical Device Labeling Processes: For conforming Product Labels, IFU and Marketing Material
The Importance of Effective Labeling Labeling is a critical aspect of medical device development and regulatory compliance. A clear,...
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Nov 15
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
Most Important Links to Regulations and International Standards Medical Devices
International Standards Medical Devices Links and Tipps
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Oct 25
EU-AI Act and Medical Devices: Looking for Manufacturers for a Semester Project on Compliance Assessment
Have your medical devices assessed for compliance and tackle the challenges of the EU-AI Act efficiently. We’re offering up to 3...
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Sep 30
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 Alignment with...
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Sep 20
Medical Device Compliance: Balancing Cost versus Risk
In the medical device industry, balancing compliance costs with the need for speed and innovation is a constant challenge. How does your...
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Sep 6
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
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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Jun 17
AI in Compliance Work: ColabON's Vision
The following Promt generated this image: is the image with the vision statement "From Regulation to Registration," using the Colabon...
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May 6
AI+ Regulation
Save the date! On June 26, 2024, an exciting event on the topic of AI + Regulation will take place at the Kaufmännisches...
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Mar 19
Current List of Harmonized Standards medical devices and IVDs
#harmonisedstandardsmedicaldevices #harmonizedstandardsmedicaldevices
#listofharmonizedstandardsmedicaldevices
#harmonisedstandardsivds
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