Training resources

Download individual medical device training course pdfs below.

• Introduction to CE Marking (PDF)

• Medical Device CE Marking (PDF)

• Introduction to CE Marking for In Vitro Diagnostics (PDF)

• Application of In Vitro Diagnostics Directive (PDF)

• ISO 13485:2016 Transition (PDF)

• ISO 13485:2016 Auditor Refresher (PDF)

• 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)