Usability Engineering in the medical device industry in the European Union: responsibilities and obligations focusing on the MDR and IEC 62366-1
Learning goals
The participants know and understand…
1. … what usability means and why it is important
2. … the European regulation on usability ( MDR and EU standards )
3. … how usability should be implemented with the 62366-1 standard
Content
1. Introduction to usability
2. Usability definition
3. MDR and usability
4. EU norms for usability
5. Usability and 62366-1- normative requirements
6. Conclusions
Link to Post-Market Surveillance video:
[ Ссылка ]
