Clinical Evaluation – Burden or Chance? Workshop on Clinical Evaluation of Medical Devices – Practical Application of MEDDEV 2.7.1 Rev 4 and Medical Device Regulation (2017/745)

This workshop on clinical evaluations of medical devices provides you an overview on the general regulatory requirements according to the MEDDEV 2.7.1 Rev 4 and the Medical Device Regulation 2017/745. In the course of the workshops you will face different challenges implementing a clinical evaluation plan as well as a literature search. Finally, you will bring the information collected during the day together in a draft clinical evaluation report and learn "hands on“ the Dos and Don’ts in preparation of clinical evaluation reports.

Topics:

  • Regulatory requirements in regards to clinical evaluations
  • Differences and changes from medical device directive to medical device regulation
  • Post market surveillance and post market clinical follow up
  • Clinical evaluation during product lifecycle
  • Clinical evaluation and product development
  • Clinical evaluation and risk management
  • Preparation of clinical evaluation plan
  • Practical implementation of guidance on clinical evaluation plan and literature search
  • Practical implementation of guidance on clinical evaluation reports
  • Pitfalls during preparation and update of clinical evaluations
Details
Note: 
New!
Target audience: 
The course is best suited for managers and employees that write, review, update and/or take responsibility for clinical evaluations, research and development, regulatory affairs, clinical safety, risk management, quality management.
Participants: 
approx. 10
Language: 
German
Requirements: 
Basic experience in preparation of clincal evaluations would be an asset but are not a precondition.
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