In recent years, US and global regulatory agencies have placed greater emphasis on human factors requirements for medical devices and combination products. The FDA’s Human Factors Engineering guidance and IEC 62366-1:2015 detail the process manufacturers must follow. However, due to great diversity in the devices being created, many struggle to understand how the regulations should be applied to their specific devices.
The RAPS San Francisco Bay Area chapter invites you to participate in an online webcast to explore this important topic. The session will provide a general introduction to usability engineering and testing, particularly as it applies to Class II medical devices. The presenters will also provide an overview of compliance risks and explore the impact of not conducting usability studies prior to a 510(k) submission.
- understand how incorporating usability into the design control process enables tighter timelines, better products and regulatory acceptance
- list the key requirements related to conducting usability studies per FDA regulations
- factors to consider regarding usability early in the design process
- learn about usability case studies and how to apply the regulations to Class II device(s)
- become equipped on how to mitigate compliance risks
All you need to participate in this live webcast is internet access and a telephone connection. Our subject matter experts will virtually deliver their presentation, while participants simultaneously view the PowerPoint slides on their own computers. Audio is available via the internet as well as by dialing-in. During the Q&A, participants will have the opportunity to have their questions answered by the presenters. Registrants will also have 12 months of access to the on-demand recording of the session on the RAPS Learning Portal.
This activity is brought to you by the RAPS San Francisco Bay Area chapter and is intended to provide convenient access to valuable content for those in the regulatory community. Webcast participants may claim 1.5 hours of educational credit or 1.5 RAC recertification credits.
Jason Amaral, managing partner at Emeraldwise
Amy Kerdok, PhD, director, clinical and product development, Outset Medical
Jennifer Mascioli-Tudor, MBA, vice president, quality assurance and regulatory affairs, Outset Medical