ISO 13485:2016 Medical Devices Quality Management

FQA offers its Certification exam and self-study/blended Training courses at 3 levels (Foundation, Specialist, Professional). To understand more about the 3 levels, click here

For your ISO 13485:2016 Medical Devices Quality Management Certification Exam, you can choose between the 3 exam levels as below:

  • Foundation level exam – 60 multiple choice questions (MCQs). 60 minutes
  • Specialist level exam – 90 multiple choice questions (MCQs). 90 minutes
  • Professional level exam – 120 multiple choice questions (MCQs). 120 minutes

For the ISO 13485:2016 Medical Devices Quality Management self-study/blended Training Courses, we suggest that you choose the course which is the same level as the above Exam. For detailed information, please access:

ISO 13485:2016 Medical Devices Quality Management

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Implementing ISO 13485 brings several benefits to organizations operating in the medical device industry. Here are some key advantages:

  • Enhanced Product Quality
  • Efficient Processes
  • Competitive Advantage
  • Supply Chain Confidence
  • Traceability and Documentation
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