Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course (Nov 28 - 29, 2022)

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course is organized by Management Forum (Mf) Ltd.

Course overview:
This two-day introductory course will cover all aspects of clinical evaluation in line with the European Medical Device Regulation (MDR) and applicable guidance documents. The programme will provide you with the tools and skills you will need to produce a high-quality clinical evaluation report (CER) for all your medical devices. You will understand the detail of what clinical data is needed, how to collect it, analyse it and produce a CER that is acceptable to the regulatory authorities and Notified Bodies. You will learn how the process fits into the development of a medical device and also the post-market aspects of clinical evidence.
The program includes case studies and template documents which you will be able to utilize to produce your own clinical data evidence documentation.

Benefits of attending:
• Gain a detailed overview of the clinical evaluation process
Understand the concepts • involved in conducting a clinical evaluation
Learn how to utilize information gathered • during a clinical evaluation
Take away skills in conducting a systematic literature search
 • Learn how to appraise data
 Know how to assemble clinical evidence acceptable for • review by regulatory authorities or Notified Bodies