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Clinical Evaluation of Medical Devices: The Clinical Evaluation Report


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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

Details

Course overview

  • 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

Why you should attend

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.

Prices

TBC

Contact

Leigh White
info@management-forum.co.uk

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