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Training resources

Download individual medical device training course pdfs below.

  • Introduction to CE Marking (PDF)

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  • ISO 13485:2016 Transition & Auditor Refresher (PDF)

  • Introduction to ISO 13485:2016 (PDF)

  • ISO 13485:2016 Clause by Clause (PDF)

  • Implementing ISO 13485:2016 (PDF)

  • Internal Auditor ISO 13485:2016 (PDF)

  • Lead Auditor ISO 13485:2016 (PDF)

  • Creating and Maintaining Technical Files and Design Dossiers (PDF)

  • Introduction to Risk Management for Medical Devices (PDF)

  • Clinical Evaluation for Medical Devices (PDF)

  • Post Market Surveillance and Vigilance (PDF)

  • CE Marking Medical Devices with Software (PDF)

  • Process Validation for the Medical Device Industry (PDF)

  • Device-Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process (PDF)

  • Medical Devices Utilizing Material of Animal Origin (PDF)


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