Best Practices for EUDAMED Compliance

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 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 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.

Kim Guihen is a senior leader in the life sciences and MedTech space, specializing in digital transformation, regulated technologies, and global compliance. As SVP of Strategic Alliances and Digital Transformation at USDM Life Sciences, she works closely with MedTech and life sciences organizations to enable innovation while meeting stringent regulatory requirements. With more than 20 years of industry experience, Kim is widely recognized for her expertise in GxP compliance, cloud and digital platforms, and the application of emerging technologies—including AI and data management—to highly regulated environments. She leads strategic partnerships with major technology providers and plays a key role in advancing compliant, scalable solutions that support quality, security, and regulatory readiness across the MedTech ecosystem.