Boston Chapter Virtual Event: Standards and ASCA: The Ultimate Regulatory Weapon

This session will demonstrate the value of standards, explain how to cite them to maximize efficiencies, describe the process for an ASCA test and how the industry uses ASCA.

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.

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 [email protected]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 [email protected] 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 [email protected]

Speaker

Eric  Franca

Eric Franca

Director of Conformity Assessment Program, FDA

Find out more

 

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