Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies. The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives.
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Suitability - Who should attend?
Benefits of attending
- Gain an insight into medical device clinical studies
- Stay updated of the regulatory changes
- Learn the methods of handling adverse events during the study period
- Discuss the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance
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Reviews by course attendees
Average rating 4.5
Excellent course, excellent trainer. Found it very valuable and will be taking away knowledge gained to further improve processes and understanding within my department.
Fantastic speaker. I truly enjoyed listening to Janette, her ability to relate real life examples helped make sense of the topics.
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
Understanding what requirements for RA through the cases of Medical Devices studies is very important for me to deal with Korean Medical devices. So this course make me more kno...