Houston's medical device ecosystem is expanding rapidly, and with that growth comes a pressing need for regional professionals to stay ahead of evolving regulatory pathways. RAPS Houston LNG is proud to present the FDA ASCA Program Roadshow Panel Event with Biotex, Inc. in partnership with TMC Innovation Factory.
This event is designed to educate regional manufacturers, laboratories, and regulatory professionals on the Accreditation Scheme for Conformity Assessment (ASCA) — an FDA program that allows accredited testing laboratories to verify that certain medical devices conform to recognized standards, helping streamline premarket submissions and reduce regulatory bottlenecks.
Attendees will hear directly from an FDA representative on the goals and mechanics of the ASCA program, followed by a presentation from Wade Munsch of Biotex, Inc, the only Houston-area laboratory to have attained ASCA accreditation. The evening will close with an interactive panel Q&A, giving attendees the opportunity to engage directly with both FDA and industry perspectives, followed by a networking reception.
This event is tailored for medical device regulatory affairs professionals, quality engineers, testing laboratory managers, and life science innovators seeking practical, actionable insight into how ASCA can support faster, more efficient paths to market.
Agenda
Location
TMC Innovation Factory
2450 Holcombe Blvd.
Suite X, Gate 2450
Houston, TX 77021
*Parking is free for the first two hours and then $11 for next 30 minutes.
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].
Speakers
Shireen Fotelargias
