Training resources
Download individual medical device training course pdfs below.
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Introduction to CE Marking (PDF) >
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Medical Device CE Marking (PDF) >
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Introduction to CE Marking for In Vitro Diagnostics (PDF) >
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Application of In Vitro Diagnostics Directive (PDF) >
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ISO 13485:2016 Transition (PDF) >
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ISO 13485:2016 Auditor Refresher (PDF) >
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ISO 13485:2016 Transition & Auditor Refresher (PDF) >
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Introduction to ISO 13485:2016 (PDF) >
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ISO 13485:2016 Clause by Clause (PDF) >
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Implementing ISO 13485:2016 (PDF) >
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Internal Auditor ISO 13485:2016 (PDF) >
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Lead Auditor ISO 13485:2016 (PDF) >
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Creating and Maintaining Technical Files and Design Dossiers (PDF) >
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Introduction to Risk Management for Medical Devices (PDF) >
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Clinical Evaluation for Medical Devices (PDF) >
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Post Market Surveillance and Vigilance (PDF) >
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CE Marking Medical Devices with Software (PDF) >
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Process Validation for the Medical Device Industry (PDF) >
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Device-Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process (PDF) >
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Medical Devices Utilizing Material of Animal Origin (PDF) >
