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

David Wolf, Director of Global MedTech PLM Sales, PTC

Expert Panel Discussion and Q&A

Lionel Tussau, Regulatory Strategy Expert, osapiens, Jeff Holzman, Global Lead: Strategy & Partnerships, osapiens, David Wolf, Director of Global MedTech PLM Sales, PTC, and Blake Snell, Senior Manager, Kalypso

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.

David Wolf

Director of Global MedTech PLM Sales, PTC

David Wolf is Director, Global MedTech PLM Sales at PTC. He helps medical device and life sciences organizations connect the digital thread—from engineering and quality to regulatory—so they can accelerate innovation while meeting compliance. As co‑chair of PTC’s Healthcare Executive Advisory Council, David convenes industry leaders to share proven practices that improve patient safety and operational performance. A results‑driven commercial and delivery leader, he has led enterprise software initiatives spanning solution development and validation, pricing and contracting, and organizational change management. His work focuses on practical transformation: implementing PLM and digital QMS capabilities, strengthening documentation and traceability, and driving measurable outcomes through data‑driven KPIs. A frequent presenter and panel host at MedTech forums, David offers clear, actionable guidance on regulatory readiness, digital manufacturing, and the business value of the digital thread—helping teams turn strategy into measurable results.

Blake Snell

Senior Manager, Kalypso

Blake Snell is a Senior Manager at Kalypso, a Rockwell Automation business, where he helps medical device and life sciences organizations modernize operations across the digital thread—connecting product development, manufacturing, and quality systems to deliver measurable outcomes in speed, compliance, and reliability. Based in Boston, he leads enterprise programs that integrate PLM with MES and ERP, guides validation and global rollout strategies, and partners with executive stakeholders to align technology with business and regulatory goals. His background spans hands‑on roles in Quality and R&D at Mölnlycke Health Care and Morgan Scientific, bringing a practical, patient‑centric lens to digital transformation. Blake holds a Bachelor of Science from the University of Maine and an MBA with a concentration in project management.

Join us at Coach Grill

This Lunch & Learn will be hosted in a private room at the Coach Grill in Wayland, MA. You’ll enjoy all the comforts of a traditional New England meal, from the finest, aged steaks and chops to fresh seafood, paired perfectly with an extensive array of classic wines.

Venue Address: 55 Boston Post Road Wayland, MA 01778

See Restaurant Details

Attend the Lunch & Learn in another city

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