The European Conference on Clinical Studies with Medical Devices and IVDs (CSMD2020) is dedicated to the most challenging and perplexing aspects of planning and conducting medical device and IVD clinical studies.
Topics
- Notified Body assessment of clinical study strategies
- Competent authority views on managing MDR clinical study applications
- International standard for conducting medical device studies: revised ISO 14155
- Industry view on implementation of MDR clinical study requirements
- Clinical Investigation Plans that meet regulatory and operational requirements
- International standard for conducting IVD clinical performance studies: ISO 20916:2019
- Critical considerations in site selection and subject enrollment
- Key statistical elements of a successful clinical study
- New medical device clinical safety reporting requirements
- PMCF investigations, regulatory requirements and practical considerations
- Effective compliance with clinical study-related European privacy requirements
- Investigator-initiated studies, new requirements, new considerations
Who should Attend
Attendees involved in designing, planning, sponsoring, conducting, assisting and evaluating in medical device or IVD clinical study-related activities.
