Presenter

Denise Forkey has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. As the Human Factors Engineering Manager at UserWise she leads usability engineering projects for injectables through robotic surgery systems and partners with UserWise clients on domestic and international human factors regulatory strategy.
Denise has experience developing instructions for use; creating use-related risk analyses; and executing formative and summative usability evaluations; authoring Human Factors Engineering Submission Reports for FDA; and providing human factors engineering training sessions. She also assists UserWise clients with gap analyses and compliance documentation for IEC 62366-1, IEC 60601-1-6, and FDA Human Factors Guidance Documents.