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    • Market Access
      • Market Access US & International
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      • And more…
    • Quality System
      • Quality management systems (ISO 13485)
      • ISO 13485 audits
      • Quality management representative
      • Quality management system as a service
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      • Software (IEC 62304, FDA)
      • Risk Management (ISO 14971)
      • Clinical Evaluation
      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
    • Product test
      • Human Factors Research
      • Safety and EMC test laboratory
      • Biological safety
      • Computer System Validation
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      • Seminar Overview
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August 22, 2023


CE mark, CE marking for medical devices

By Florian KrafftAugust 22, 2023Leave a comment

This article describes when and why manufacturers must affix a CE mark, what is meant by CE marking, and what manufacturers must do up to that point.

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