This webinar will provide an overview of how standards solve real-world problems in medical device development and oversight. Standards are widely recognized as essential tools that support the design, manufacturing, testing and regulation of medical devices, and they play a vital role in advancing safety and public health. When manufacturers rely on FDA-recognized standards, their submission documentation can be less burdensome and more streamlined. The session will showcase the value of standards, outline how to reference them to maximize efficiencies, and walk through the ASCA testing process and how industry applies ASCA in practice.
Registration Fees & Deadlines
Member:$0 | Nonmember:$25 | Student Members:$15
Speaker
Eric Franca
Director of Conformity Assessment Program, FDA
Eric Franca received his PhD in Biomedical Engineering from the University of Florida where he investigated novel carbon nanomaterials for developing more effective neural electrodes. He began his professional career as a lead reviewer of medical devices at the Food and Drug Administration. He subsequently moved into a policy analyst position managing the content and publication of guidances, orders, and regulations related to medical device review and CDRH policies. He currently serves as Director of the Conformity Assessment Program in his role as an Assistant Director in CDRH’s Division of Standards and Conformity Assessment. Concurrent with his work as a regulator within the FDA, Dr. Franca has participated in standards development, serving in leadership positions within the US National Committee to the IEC and as an US technical expert on several standard development committees.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
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
support@raps.org.