Clinical Evaluation of Medical Devices: The Clinical Evaluation Report is a course dedicated to all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance.
Topics
- The concepts involved in conducting a clinical evaluation
- Detailed overview of the clinical evaluation process
- Where clinical evaluation fits in the development and marketing of medical devices
- How to utilise information gathered during a clinical evaluation
- How to appraise data
- Skills in conducting systematic literature searches
- How to assemble clinical evidence acceptable for review by Regulatory Authorities or Notified Bodies
Who should Attend
Attendees involved or interested in:
- Medical writing
- CROS
- R&D
- Gathering clinical evidence and conducting clinical evaluations
- Regulatory affairs
- Clinical staff
- Moving from Pharmaceuticals to Medical Devices
- Clinical evaluations/investigations/post-market follow up studies
