Global regulatory compliance is more complex than ever for medical device manufacturers. From EUDAMED and GUDID to GDSN and TGA, companies must manage diverse data requirements, ensure validation, and maintain visibility across markets.
In this session, discover how PTC Windchill and BYRD Health, in collaboration with USDM, deliver a unified, validated, and scalable solution for regulatory data management, submission, and syndication. Learn how to centralize product data, automate submissions, and track statuses across global agencies—all from a single source of truth.
We’ll walk through:
- Key regulatory systems: EUDAMED, GUDID, GDSN, TGA
- Cloud Assurance and validation support with USDM
- A typical PTC + BYRD implementation roadmap
- A live demo of our Proof of Concept
- Open Q&A with our expert panel
Key Takeaways
- Understand the regulatory landscape across EU, US, and globally
- See how Windchill & BYRD simplifies data syndication and compliance
- Learn how Cloud Assurance accelerates validation for Medtech
- Get a real-world look at implementation and live system capabilities
Planning on joining in-person? Please join us at this location:
Once registered, you will receive a confirmation e-mail with the location.
The in-person sessions will take place in Mannheim, Germany.
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Speakers
Jeff Holzman
BYRD Health, Global Lead, Strategy & Partnerships | Commercial Lead, Americas
Lionel Tussau
BYRD Health, Regulatory Strategy Expert
Jay Crowley
Global Compliance Lead, USDM, and former lead of the UDI regulation at the FDA
Ameur Handous
BYRD Health, Lead Services Healthcare
