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Topics
- Medical Device Regulation 2017/745 (MDR), MDCG documents, ISO 14155:2020, Declaration of Helsinki, and GDPR
- Basics of clinical evaluation, clinical data, the relationship between PMCF and clinical evaluation (CEP, CER), and legal requirements for PMCF activities
- Different possibilities of PMCF measures, PMCF plan, PMCF report, PMCF and inventory products, as well as PMCF and new product development
Trainers
Kirsten Sander, MSc Biology, is the Country Manager of Aurevia GmbH in Germany. She has been working in clinical research for more than 10 years, with experience in medical and scientific writing, monitoring, and project management. She has in-depth knowledge of regulatory requirements for clinical investigations (EU MDR, MDCG, ISO 14155, German MPDG), clinical evaluations, and post-market clinical follow-ups.
Target group
People working in clinical research, safety reporting, regulatory affairs, and quality management.Objectives
After the course, participants will:- Be familiar with the specific regulatory requirements for post-market clinical follow-up activities with medical devices
- Be able to develop a PMCF plan and synopsis
- Be aware of the different options which exist in terms of PMCF measures
- Understand which ethical, scientific and quality aspects need to be considered
- Be equipped to plan, conduct and evaluate post-market clinical follow-up activities and understand the different options