Training #02

Training in clinical evaluation of medical devices

Training methods

Prerequisites

  • None

Target audience

People involved in :

  • The design of medical devices,
  • Regulatory affairs,
  • Anyone involved in the clinical assessment process.

Further information

  • Location: Face-to-face or distance learning
  • Date: Thursday, June 5, 2025
  • Duration: 1 day (7 hours)

Training content

Know the methodology for carrying out the clinical evaluation of your medical devices according to Regulation (EU) 2017/745.

  • Post-training evaluation questionnaire
  • Training satisfaction evaluation questionnaire

Each participant will be able to :

  • Determine when a clinical assessment should occur and how often updates should be made
  • Determine the type of clinical data needed
  • Carry out a clinical development plan
  • Write a clinical assessment plan
  • Write a clinical assessment report
  • Carry out a literature search and know how to judge the relevance of the data collected

  • Detailed training schedule
  • Digital training materials
  • Training evaluation questionnaires
  • Results of trainee learning assessment
  • Training certificate

  • Normative and regulatory requirements relating to the clinical evaluation of medical devices
  • Terminology related to the clinical evaluation of medical devices
  • Methodology and tools for constructing a clinical evaluation relating to medical devices

Starting at €980
Price adapted to your needs, number of participants and type of training (inter / intra-company).
Contact us for a personalized quote

 

  • Teaching aids (course support presentation, extracts from standards documents, document templates, etc.)
  • Practical exercises, feedback, case studies based on your system

Interested in this course?

Contact us for details and deadlines!
If you'd like to register directly, we'll send you a detailed quote and schedule.

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