Live Webinar
Go-to-Market in the US with Medical Devices: Demystifying FDA Regulations
Legal risk, ERP execution and what it really takes to launch in the US
May 21, 2026 | 10 AM ET / 4 PM CET | Microsoft Teams
Taking a medical device into the US is not only about choosing the right FDA pathway. It affects how you design your quality system, manage suppliers, validate software, and prepare for audits on both sides of the Atlantic.
In this webinar, legal and technology experts walk through the practical implications of recent and upcoming FDA expectations for medical device manufacturers. We connect the legal and regulatory view of risk with the ERP and business software view of execution, so you can turn compliance pressure into a predictable go-to-market journey.
What you'll learn:
-
How FDA classifications work and where they differ from EU rules.
-
The essentials of 510(k) and PMA and how they affect timelines.
-
Key expectations for audits, cybersecurity and documentation.
-
How ERP and eQMS support audit‑readiness and compliance.
Speakers
Thomas Van Dorpe - AI & ERP Solution Architect at Cegeka
Allyson M. Maur - Partner at McGuireWoods LLP
Register now!
Register now and get a clear, practical view of what FDA regulations mean for your device, documentation and ERP landscape when entering or expanding in the US market.
Digital Innovation in Pharma & MedTech
Discover the full webinar Series
This webinar is part of our Digital Innovation in Pharma & MedTech series, designed to help industry leaders turn disruption into opportunity. Join us to tackle the most critical challenges shaping Pharma and MedTech today, from AI adoption and compliance to ERP validation, data integration, global roll-outs and supply chain resilience.
We believe in shaping digital together. We don’t just deliver technology, we work shoulder to shoulder with our clients to ensure technology drives impact when and where it matters most.
Discover more
Solutions
Services
Industries
Careers
About Us
Why Cegeka
The Cegeka Story
Cegeka & Society
Annual Report
Let's get in touch
Have questions or want to connect? Get in touch through our contact form to start the conversation.
Privacy
Cookies
Terms of Use
Accessibility
Do Not Sell or Share
© Cegeka