Regulatory Affairs: Upping Your Conformity Assessment Game

Putting Standards to Work to Streamline Device Review

Standards solve problems. They are universally valued as important and valuable tools to support the design, manufacture, testing, and regulation of medical devices. They play a key role in promoting safety and public health. When manufacturers rely on FDA-recognized standards, submission documentation is less burdensome and more streamlined.

This session will demonstrate the value of standards, explain how to cite them to maximize efficiencies, including in eSTAR, and introduce participants to the FDA’s latest program to enhance standards’ use: the Accreditation Scheme for Conformity Assessment, or ASCA.

Food will be provided at this event.

Registration Fees & Deadlines
Member $25| Nonmember $45 | Students $10

Sponsors

This event is organized by the San Francisco Bay Area Chapter of the Regulatory Affairs Professional Society (RAPS) and co-sponsored by the Regulatory Affairs Certificate Program at UC Santa Cruz Professional Education in Silicon Valley.