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Nov 27
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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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 What is the...
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