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Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Management Forum
Course summary
2 days
English
London
Next available date: 03/12/2020 - London
Professional Training

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

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 programme includes case studies and template documents which you will be able to utilise 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 utilise information gathered during a clinical evaluation
  • Take away skills in conducting systematic literature searches
  • Understand where clinical evaluation fits into the development and marketing of medical devices
  • Learn how to appraise data
  • Know how to assemble clinical evidence acceptable for review by regulatory authorities or Notified Bodies

Who Should Attend

  • CROs
  • Medical writers
  • Clinical staff
  • Those who conduct clinical evaluations/investigations/post-market follow-up studies
  • Those moving from pharmaceuticals to medical devices
Personnel involved in:
  • Gathering clinical evidence and conducting clinical evaluations
  • R&D
  • Regulatory affairs

Provider: Management Forum

Management Forum

Management Forum - Professional training courses for the Life Sciences and Intellectual Property Sectors

Management Forum is an internationally renowned training provider organising professional conferences, seminars and in-house courses for professionals and companies in the Life Sciences and Intellectual Property sectors. With their growing programme portfolio, training specialists at Management Forum aim to provide...


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Reviews by course attendees

Average rating 4.7

Based on 6 reviews

Lise
(5)
Communication very clear. Immense knowledge and experience. Entertaining. Very open re. questions. Made everybody feel well and acknowledged. Able to create team spirit. Structured. Kept time. Good flow. Fantastic overview with an eye on the details. What's not to like :)
Karen
(5)
Very good teacher. No doubt that she knows what she is talking about and I got more out of the training than I had hoped for. I really liked that we were so few people attending the training, so there was plenty of time to asking questions and discuss the topics.
Per
(5)
Janette was both very proficient regarding CE both also a lively and engaging presenter. It was a very good course, both content and duration was great
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