Usability engineering according to IEC 62366-1

Usability engineering according to IEC 62366-1
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Usability is an integral part of medical device development. Thus, it is important to understand how users may interact with a device, in order to ensure proper function and avoid safety issues.

To reduce the risk of use errors, the Medical Device Regulation (MDR) requires that medical devices be designed with specific focus on the characteristics of the intended users. The IEC 62366-1 standard describes the various activities that should be implemented in a usability engineering process to fulfill the requirements of the MDR.

Topics

  • IEC 62366-1:2015 – History and regulatory context
  • Usability – terminology and definitions
  • The usability engineering process – step by step
  • Formal usability validation
  • Legacy devices

Course presentations

Course material, verbal presentation and discussions will be in English.

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Information

När: tors, 19 maj 2022 09:00 till 16:00
Var: ONLINE
Arrangör: QAdvis
Språk: Engelska
Pris: 6600 SEK
exkl. moms

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Kategori

Seminarium/utbildning

Kontaktinformation

QAdvis
+46-(0)8-621 01 05
academy@qadvis.com
https://www.qadvis.com/portfolio-item/usability-engineering-according-to-iec-62366-1/