;   Medical Translation Insight: Human factors engineering a big hit in Minneapolis - ForeignExchange Translations

Human factors engineering a big hit in MinneapolisAs we have seen before, human factors engineering (HFE) and usability testing is a hot topic these days.

FDA's draft HFE usability guidance was issued a few months ago and drew lots of commentary from industry. While there is not yet any target date for a final guidance to be issued, industry is already preparing for the inevitable: human factor engineering and usability testing will be critical to meet FDA's requirements.

To help medical device companies navigate this transition, we have teamed up once more with Maria Shepherd of Data Decision Group. A few days ago, Maria led a two-hour discussion in Minneapolis around the topic of HFE.

Attendees from Boston Scientific, Incisive, Medrad, Medtronic, Patterson, Smiths, and Teleflex shared war stories, challenges, and experiences navigating FDA's changing rules. Maria shared insights into guidance documents, standards (such as HE 75 and ISO/IEC 62366), as well as best practices, including how to turn HFE usability into a systemic process (click on image for larger version).

If you couldn't make it to Minneapolis, you can still benefit from Maria's expertise. She has produced two events on HFE. HFE 101: New FDA Draft Guidance on Human Factors Engineering and Usability Testing is intended for audiences that are just getting started with HFE and usability testing. Advanced Human Factors Engineering is useful for professionals who already understand HFE and are looking for more in-depth information.

ForeignExchange translates IFUs, software UIs, and training programs for medical device companies. For specialized medical translation services, contact us today!


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