Clinical evaluation for Medical devices
Our Clinical Evaluation for Medical Devices one-day course is designed to support manufacturers by confirming the information necessary to demonstrate clinical safety and performance of their product in accordance with the requirements of the European Medical Devices Directive.
On completion of training, manufacturers will be able to determine if a clinical trial is required, prepare a clinical evaluation report including literature review and determine requirements for post-market clinical follow-up and post-market surveillance to support continuing compliance.
- Familiarity with own device clinical safety and performance issues
- Awareness of:
Essential Requirements (Annex I) and Clinical Evaluation (Annex X) of the European Medical Device Directive or Essential Requirements (Annex 1) and Clinical Evaluation (Annex 7) of the European Active Implantable Medical Device Directive
MED DEV 2.7.1 or GHTF guidance document SG5/N2R8