Clinical Evaluation & Post-Market Surveillance
This course is a practical guide to assembling a clinical evaluation plan and report in accordance with the requirements of the Medical Device Regulation. Additional requirements and the gap between the current Medical Device Directive and the regulation. How to go from the stated objectives:
Risk v benefit
Other claims made by the manufacturer
To conclusions which address each in turn
This course also explores the interactions between clinical evaluation and post-market surveillance and how they influence other aspects of the quality management system.
A practical guide to post-market surveillance
Sorting devices by risk
Dealing with adverse events
Trending and reporting
Who should attend:
The content will have great value to individuals who are involved in any aspect of implementing or maintaining a clinical evaluation.
Quality Assurance Professionals
Research and Design Engineers
Delegate cancellation policy
Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.
Photography at events
There may be a photographer and videographer at the event and we may publish images from this event on our website(s) and on our social media accounts.