Usability Engineering in the medical device industry in the European Union скачать в хорошем качестве

Usability Engineering in the medical device industry in the European Union

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:    • Post-Market Surveillance for medical devic...