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2019 - The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

Date2019-07-09

Deadline2019-07-09

VenueOnline Event, USA - United States USA - United States

KeywordsIEC 62366-1; Usability engineering; US FDA guidance

Websitehttps://www.complianceonline.com/new-usa...

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

Last modified: 2019-06-24 00:22:19