UL's Allison Strochlic presenting "Applying Human Factors Engineering to Support FDA and CE Mark Submissions"
Today, human factors engineering (HFE) is an imperative. FDA’s human factors engineering (HFE) guidance (published in June 2011) and IEC 62366:2007 (Usability) place intense HFE expectations on medical device developers. These high expectations apply to new products and, in some cases, existing (i.e., legacy) devices. Manufacturers face the imperative to apply HFE thoroughly to ensure their products are competitive in a market that increasingly rewards good user interface design.
During this 90-minute talk, UL’s Allison Strochlic, the HFE team research director and co-author of the book Usability Testing of Medical Devices, will provide a general introduction to human factors engineering practices aligned with today’s regulations and standards. She will share tips on effective strategies to fulfill both FDA’s expectations and those established by the IEC standard, which is applied by many other regulators. Following the talk, Strochlic will answer attendees’ HFE-related questions.
UL, a global company providing full support for regulatory approvals throughout the product lifecycle, provides world-class HFE support that can be integrated with UL’s other advisory and compliance services. UL’s customers can access HFE experts based in multiple locations, including the USA, Europe and Asia. UL’s HFE services include program planning, user research, user interface design support and critiques, use-related risk analysis support, and formative and summative (i.e., validation) usability testing.
Free parking is in the building. Light refreshments will be available to all meeting participants. Attendees may claim one and a half (1.5) RAC recertification credits.
This meeting is sponsored by the RAPS Texas Chapter to promote knowledge advancement and facilitate networking among local regulatory professionals.