Standards solve problems. They are universally valued as important and valuable tools to support the design, manufacture, testing, and regulation of medical devices and, as such, play a key role in promoting safety and public health. When manufacturers rely upon FDA-recognized standards, EU-harmonized 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.
In addition, we will get an overview of current stand of Swissdamed, the Switzerland database.
Registration Fees & Deadlines
Free
Speakers
Stacy Cho
senior health policy analyst with the Division of Standards and Conformity Assessment Program (DSCA) at the Center for Devices and Radiological Health, FDA
André Breisinger
Medical Devices Regulation Expert, Swissmedic
Platinum Chapter Sponsors
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org