AAMI Webinar on HFE Reports for Medical Device Manufacturers
March 15, 2018
By Neozene

A new webinar hosted by the Association for the Advancement of Medical Instruments (AAMI) will provide insights into preparing Human Factors Engineering (HFE) test plans and reports that existing regulatory guidance does not fully address.

The AAMI webinar, “Writing Human Factors Plans and Reports,” has been developed to cover the lack of sample work products in HFE guidance documents issued by the US Food and Drug Administration and other regulators.

The webinar takes place March 15, 2018 at 11am Eastern US time. Topics the webinar will cover include:

• HFE project plans
• Formative usability test plans and reports
• Summative usability test plans and reports
• HFE reports

Webinar presenters will include Michael Wiklund, Laura Birmingham and Stephanie Larsen of UL Wiklund. The webinar coincides with a new AAMI book, Writing Human Factors Plans & Reports for Medical Technology Development, authored by the webinar presenters.

The webinar’s target audience includes human factors engineers, user experience designers and researchers, quality engineers, regulatory affairs professionals and related personnel involved in HFE and usability issues in medical devices.

The Regulatory experts at Neozene can help your organization establish all processes necessary to meet all regulatory requirements. Whether these requirements are for regulatory submissions, licensure, general compliance, or training, our team of experts will efficiently and effectively establish or assist in establishing a regulatory infrastructure that will withstand scrutiny of any regulatory body in the world.