2019 - The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016
Date2019-07-09
Deadline2019-07-09
VenueOnline Event, USA - United States
KeywordsIEC 62366-1; Usability engineering; US FDA guidance
Topics/Call fo Papers
Key parts of IEC 62366-1
Written for easier to understand intent / implementation
Part 1 focuses on “what”, Part 2 on “how”
Closer ties to ISO 14971, Medical Device Risk Management
Closer adherence to US FDA guidance; more harmonization
Planning requirements
Defined engineering process
User interface considerations
Written for easier to understand intent / implementation
Part 1 focuses on “what”, Part 2 on “how”
Closer ties to ISO 14971, Medical Device Risk Management
Closer adherence to US FDA guidance; more harmonization
Planning requirements
Defined engineering process
User interface considerations
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Last modified: 2019-06-24 00:22:19