Training #05

Training in usability of medical devices in accordance with NF EN 62366-1 standard

Training methods

Prerequisites

None

Target audience

People involved in :

The design of medical devices
Regulatory affairs
Any person involved in the usability engineering process

Further information

Location: Face-to-face or distance learning
Date: Tuesday, April 1, 2025
Duration: 1 day (7 hours)

Download the training sheet

Training content

Know the methodology for carrying out the validation of the suitability for use of a medical device.

Post-training evaluation questionnaire
Training satisfaction evaluation questionnaire

Each participant will be able to :

Know and understand the requirements of the standards in force relating to the suitability for use of medical devices: NF EN 62366-1, NF EN 60601-1-6 (for electromedical devices)
Know the principles of ergonomics applied to medical devices
Know the difference between formative and summative aptitude
Write a protocol and a suitability for use report

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

Normative and regulatory requirements relating to the suitability for use of medical devices
Terminology related to the fitness for use of medical devices
Description of the medical device usability engineering process

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