Curriculum
- 5 Sections
- 21 Lessons
- 1 Day
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- Foundations of MDR Technical Documentation3
- Structuring the Technical File6
- 2.1Device Description, Design & Manufacturing & Risk Management
- 2.2Benefit-Risk Analysis & Verification & Validation
- 2.3Country/region-specific expectations under MDR
- 2.4Notified Body audit trends: common gaps and deficiencies
- 2.5Why a Class IIb device technical file was rejected by NB
- 2.6Intended Purpose, Equivalence, Essential Requirements vs. GSPR, Design Dossier
- Real-World Documentation Challenges5
- 3.1Integration of Clinical Evaluation Reports (CERs)
- 3.2Linking ISO 14971 risk management and usability engineering
- 3.3Incorporating PMS & PMCF into living documents
- 3.4Case studies: Successful re-certification of a Class III implantable device
- 3.5Case studies: Failure case due to weak PMS evidence in technical documentation
- Interactive Documentation4
- Strategic Outlook & Wrap-Up3