The Medical Device Studies: Regulatory Requirements and Adverse Event Reporting focuses on medical device clinical evaluations, investigations, and post-market clinical follow-up (PMCF) studies, with an emphasis on adverse event reporting under the new Medical Device Regulations (MDR).
Topics
- Regulatory changes
- Medical device clinical studies
- The new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance
- Methods of handling adverse events during the study period
Who should Attend
- Quality assurance specialists
- Regulatory affairs specialists
- Junior clinical research associates
- Clinical research associates
