Join PTC & osapiens for a EUDAMED Lunch & Learn Event

EUDAMED becomes mandatory in May 2026. Are you prepared?

Overview Agenda Speakers Venue
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Shaping tomorrow, together

The EUDAMED timeline is officially confirmed. Starting May 28, 2026, all new medical devices must be registered in EUDAMED before entering the European market. Existing devices must comply by November 27, 2026. Further obligations, including the Vigilance Module, are expected in 2027. Since no extensions are possible, it is critical to act now.

EUDAMED compliance is not just a deadline issue—it is a challenge of data, processes, and coordination. Many medical device manufacturers underestimate the effort required to prepare validated device data, manage repeated testing cycles, and align with Regulatory Affairs, Quality, IT, and external stakeholders. Delayed preparation increases the risk of bottlenecks and last-minute compliance issues.

Join PTC and osapiens for an executive Lunch & Learn where you will receive:

  • A clear overview of the confirmed EUDAMED milestones and their practical impact
  • Insights into why data quality is the biggest challenge to EUDAMED compliance
  • Key steps to prioritize now: data assessment, early testing, and validated processes
  • Best practices from early EUDAMED submissions and implementation projects
  • Details on how to build a scalable foundation for EUDAMED and global UDI readiness

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Your Lunch & Learn agenda

This event provides fuel for the body and mind. Over a delicious meal, hear from leading EUDAMED experts, thought leaders from PTC and osapiens, and other industry experts. Enjoy lively discussion and networking with your peers all focused on the challenges and solutions to address EUDAMED compliance.

Time

Session Details

Presenter

11:30 AM

11:50 AM

12:10 PM

12:30 PM

12:50 PM

The Industry Impact of EUDAMED Compliance

Lionel Tussau, Regulatory Strategy Expert, osapiens

How to Run a Master Data Project for Regulatory Compliance

Jeff Holzman, Global Lead: Strategy & Partnerships, osapiens

Leveraging Windchill for Reliable UDI Data: Accelerating & Simplifying EUDAMED Compliance

Brian Veasey, Solutions Consulting Director, PTC

Expert Panel Discussion and Q&A

Lionel Tussau, Regulatory Strategy Expert, osapiens, Jeff Holzman, Global Lead: Strategy & Partnerships, osapiens, and Brian Veasey, Solutions Consulting Director, PTC

Lunch is served. Enjoy Networking & Continue Your Conversations

** Agenda Subject to Change **

Hear from MedTech compliance experts

Lionel Tussau

Regulatory Strategy Expert, BYRD Health

Lionel Tussau, chair of MedTech Europe EUDAMED IT group, member of GS1 Global Healthcare leadership team is supporting the entire Healthcare sector to manage Product information, either for UDI registration, exchange of information between trading partners, and sustainability reporting requirements. With more than 20-years experience in this area, and as Lead Healthcare for the BYRD Health company, Lionel is specialized in technology and services in the product data area. His constant relationship with regulators, GS1 organizations, trade associations and other healthcare stakeholders helps building a safer environment for patients.

Jeff Holzman

Global Lead: Strategy & Partnerships, osapiens

Jeff Holzman is a seasoned leader with over 20 years of experience in Product Master Data Management, GS1 standards, and global item data synchronization (GDSN). For the past 15 years, he has focused on medical device regulatory submissions across global agencies including FDA GUDID, EUDAMED, TGA, SFDA, and MHRA. Jeff currently leads Global Strategy & Partnerships for BYRD Health at osapiens and oversees all commercial operations in the Americas.

From 2011–2023, Jeff drove industry advancement for 1WorldSync and atrify, specializing in healthcare and medical devices. A frequent global speaker on Master Data Management, GDSN, and UDI, he co‑founded Data Sync Direct, now widely adopted by major medical device, CPG, and retail organizations.

Jeff spearheaded BYRD Health’s partnership with PTC to extend Windchill PLM with integrated regulatory and GDSN syndication capabilities. He also built BAYARD’s partnership with USDM, combining UDI syndication with expert regulatory guidance and streamlined validation through Cloud Assurance.

He has collaborated with GS1 organizations across the Americas, led influential studies on GDSN’s impact on healthcare, and authored six articles in four languages. Jeff previously managed LANSA’s Latin American and Caribbean expansion and contributed to the development of the Trade Management solution that evolved into Amber Road (E2Open). He is also a venture investor in cancer research and AI‑driven finance technologies.

Brian Veasey

Solutions Consulting Director, PTC

Brian Veasey is Director of Solutions Consulting for MedTech at PTC, partnering with medical‑device manufacturers to operationalize a compliant digital thread across design, quality, regulatory, and service. With more than a decade at PTC in technical presales and application engineering, he specializes in shaping PLM/ALM architectures that align with strict regulatory expectations while accelerating innovation and reducing risk for R&D and operations.

Brian’s work centers on design control, change management, risk management, traceability, and audit readiness—translating regulatory requirements into pragmatic workflows and measurable outcomes. Before joining PTC, he managed engineering information systems at TTI Floorcare, leading global data and process improvements in high‑volume manufacturing.

He holds a BS in Electrical & Electronics Engineering (University of Toledo) and an MBA (John Carroll University), and previously maintained the ASQ Certified Manager of Quality/Organizational Excellence credential. At this event, Brian will share actionable strategies to strengthen compliance and speed through the pragmatic adoption of PTC’s MedTech solutions.

Join us at Maggiano's Little Italy

This Lunch & Learn will be hosted in a private room at Maggiano's Little Italy in Bridgewater, NJ. You’ll enjoy a warm, classic Italian dining experience featuring generous family‑style dishes— from handcrafted pastas and house‑made specialties to comforting favorites inspired by traditional Italian recipes.

Venue Address: 600 Commons Way, Building E, Bridgewater, New Jersey, 08807

See Restaurant Details

Attend the Lunch & Learn in another city

Good news! In addition to this Lunch & Learn on February 11th in New Jersey, we will be hosting similar events with osapiens on February 10th in Massachusetts and February 12th in California. If you’re unable to join us in New Jersey or want to extend the opportunity to your team based in other locations, please consider one of the other Lunch & Learns in the series.