Essentials of European Medical Device Regulatory Affairs
Life Cycle Clinical Evaluation
Post Launch Activities
Concept
Feasibility
Development
Launch
Prototype development Bench and pre-clinical
Initial clinical evaluation ‒ Literature review ‒ Initial clinical investigations
Clinical investigations to support CE mark
Obtain CE Mark
Post marketing surveillance
User testing
Real life studies to support ‒ Reimbursement ‒ Marketing
Human factors
Studies on non CE marked products
Studies on CE marked products
The Organisationfor Professionals inRegulatory Affairs
Clinical Investigation Vs Clinical Evaluation
• The route to CE Marking - First the Clinical Evaluation then a Clinical Investigation (if required)
Clinical Evaluation (literature) Clinical Investigation
The Organisationfor Professionals inRegulatory Affairs
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