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AI in Medical Devices: Meeting EU Compliance with AI Act and MDR
The rapid adoption of artificial intelligence (AI) across multiple industries has led to the introdu
Apr 02, 2025
# MDR (EU) 2017/745 (CE Marking for Medical Devices)
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Understanding ISO 13485: Excluded Clauses vs. Not Applicable Clauses
ISO 13485 is an international standard that sets the requirements for a quality management system (Q
Mar 18, 2025
# ISO 13485
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Revision of ISO 14001 in sight
In April 2023, ISO published its results of the second User Survey on ISO 14001. The survey was orga
Feb 28, 2025
# Environmental management
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Fit for digitization: three strengths of quality management
How can quality management (QM) face up to the changes brought about by digitization in order to rem
Feb 27, 2025
# Digitalization in Quality Management
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Common Mistakes in Technical Documentation for Medical Devices Under MDR
The Medical Device Regulation (MDR) of the European Union (EU) sets stringent safety and performance
Feb 21, 2025
# MDR (EU) 2017/745 (CE Marking for Medical Devices)
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Anti-Bribery Management System ISO 37001: A Case Study
How does an ISO 37001 audit work, how can you prepare, and what added value does an ISO 37001 audit
Feb 14, 2025
# Compliance & Due Diligence
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