Each year, medical device incidents due to use/user errors caused mainly by poor user interface design are reported, some can lead to severe harm to the patients. What process is in place to limit these failures and are these avoidable?
Usability Standards (IEC 62366:2007, IEC 62366:2007+A1:2014, IEC 62366-1:2015, IEC 62366-2:2016) specifies a process for analysis, design, verification and validation of usability throughout the design and development cycle of medical devices to mitigate risked caused use/user error and poor interface design.
Medical device manufacturers marketing in Europe may apply Usability standards in order to demonstrate compliance with essential requirements of the European Medical Device Directives (MDD 93/42/EEC, IVD 98/79/EC) as well as in near future the new Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR).
This webinar discuss Usability Engineering Process, its link to Risk management and Quality management system and highlights European requirements:
- Usability and European Regulations and Standards,
- Overview of Usability Standards and the latest changes,
- Usability and Medical Device QMS.