Clinical Evaluation of Medical Devices: The Clinical Evaluation Report is organized by Management Forum (Mf) Ltd and will be held from Jun 03 - 04, 2020 at Holiday Inn London - Kensington Forum, London, England, United Kingdom.
Who should attend:
• CROS
• Medical writers
• Personnel involved in:
• Gathering clinical evidence and conducting clinical evaluations
• R&D
• Clinical staff
• Regulatory affairs
• Those who conduct clinical evaluations/investigations/post-market follow up studies
• Those moving from Pharmaceuticals to Medical Devices
Course overview:
This two day course will cover all the aspects of clinical evaluation in line with the European Medical device regulations and applicable guidance documents. The course will provide you with the tools and skills you will need to produce a high quality clinical evaluation report 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 clinical evaluation report 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 course includes case studies and template documents which you will be able to utilise to produce your own high quality 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 utilise information gathered during a clinical evaluation
• Understand where clinical evaluation fits in the development and marketing of medical devices
• Take away skills in conducting systematic literature searches
• Learn how to appraise data
• Know how to assemble clinical evidence acceptable for review by regulatory authorities or Notified Bodies
Additional details will be posted as soon as information is available.
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