This webinar explores how Quality Management Systems (QMS) evolve across the organizational lifecycle - from lean startup environments to complex global enterprises. Attendees will gain practical insights on balancing speed and compliance, designing scalable processes, while navigating resources as well as regulatory and cultural challenges at different growth stages. Learn how to navigate QMS that supports innovation while ensuring Global Regulatory Readiness in varying company environments.
This webinar explores how Quality Management Systems (QMS) evolve across the organizational lifecycle—from lean startup environments focused on agility and rapid execution to complex global enterprises that require greater structure, governance, and harmonization.
Attendees will gain practical insights into how to balance speed with compliance, design scalable processes, and adapt quality systems as organizational needs change over time. The discussion will also address how to navigate limited resources, shifting priorities, and the regulatory, operational, and cultural challenges that emerge at different growth stages.
Featuring two speakers, the session will offer separate perspectives involving both Class II and Class III Medical Devices as well as real-world experience on building a QMS that supports innovation, enables sustainable growth, and strengthens global regulatory readiness across diverse company environments.
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.
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.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
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]




Senior Regulatory Affairs Manager, Owlet Baby Care
Cydney Ryan is a Senior Regulatory Affairs Manager at Owlet Baby Care with over 5 years of experience in the medical device industry. Her expertise includes FDA 510(k) and De Novo submissions, EU MDR and RED compliance, and international market registrations across Class II prescription and OTC medical devices, and consumer electronics. Cydney is passionate about designing scalable regulatory frameworks that meet organizations where they are - and build toward where they need to go.
Senior Regulatory Affairs Specialist , BD
Becca DeFrancia is a Senior Regulatory Affairs Specialist currently at BD with over 7 years of experience in the medical device industry. Her expertise spans FDA and global regulatory submissions, quality systems of varying sizes, and regulatory strategy for Class II and Class III medical devices. Becca is passionate about helping organizations develop scalable, compliant quality systems while fostering a culture that enables innovation, sustainable growth, and global regulatory readiness.
Senior Regulatory Affairs Specialist, BD, and Seattle LNG Chair
No bio provided