Are you interested in getting insight from an FDA speaker on conformity assessment for medical devices?
The Ireland Local Networking Group are happy to invite you to our virtual event: Upping Your Conformity Assessment Game: Putting Standards to Work to Streamline Device Review.
Title of webinar ‘Upping Your Conformity Assessment Game: Putting Standards to Work to Streamline Device Review’
📅 25th November
⏲ 12 Eastern; 5pm GMT; 6 pm CET
🖥 Online attendance is free but please register your attendance Registration Link: https://bit.ly/3XIDVu3
🗣 Stacy Cho, Division of Standards and Conformity Assessment Programme, Centre for Devices and Radiological Health, FDA
BIO: Stacy Cho is a senior health policy analyst with the Division of Standards and Conformity Assessment Program (DSCA) at the Center for Devices and Radiological Health. Stacy received her B.S. in Biological Sciences and Psychology from Carnegie Mellon University and received her M.A. in Psychological and Brain Sciences with a focus on fMRI studies from Johns Hopkins University. Stacy started her career at FDA in 2013 after spending several years as a neurophysiologist with hospitals in the DC metro area. At FDA, she served as a lead reviewer for radiological devices with premarket, compliance, and postmarket submissions; and she also led the Third Party 510(k) Premarket Program. Currently, she is the Accreditation Body Lead for the Accreditation Scheme for Conformity Assessment (ASCA) program after spending several years establishing the program.
Moderator: Jamie Gallagher LNG Core Team.
📒 Key presentation and Q&A session 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, submission documentation is less burdensome and more streamlined.
Registration Link: https://bit.ly/3XIDVu3
Free to attend
https://lnkd.in/e_WGxPVr .
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.