Simplify Global MedTech Compliance With PTC Windchill and osapiens for Medical Devices (BYRD Health)

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

Ameur Handous is a customer-focused leader with 15+ years of international experience in consulting, software delivery, and project management. He leads global teams delivering complex UDI submission projects and integrations between customer ERP/PIM systems and the BYRD platform. With deep expertise in the healthcare sector, Ameur supports C-level decision-making, solution sales, and long-term client success through high-quality, scalable implementations. 

Rene Zölfl supports MedTech companies in their transformation toward greater agility through Industry 4.0 and digitalization. He built up the MedTech market at PTC in Germany. Based on his experience, he has a deep understanding of how new technologies support digital transformation, how manufacturers can benefit from digitalization in different process areas, and how regulations impact this change.

Jeff Holzman is a seasoned expert with over 20 years of experience in product master data management and GS1 standards, and 15 years specializing in global medical device regulatory submissions (FDA GUDID, EUDAMED, TGA, SFDA, MHRA, etc.). He currently leads Strategy & Partnerships for BYRD Health at Osapiens and oversees commercial operations in the Americas. He previously drove industry advancement at 1WorldSync and Atrify, and cofounded Data Sync Direct, which is now widely adopted across the healthcare and CPG sectors. Jeff has been instrumental in forming strategic partnerships with PTC and USDM to integrate regulatory and GDSN capabilities into PLM platforms and streamline UDI compliance. A frequent global speaker on GDSN, UDI, and healthcare supply chain transformation, he has published articles in multiple languages and led influential GS1 studies. His earlier work includes building LANSA’s Latin American business and contributing to the launch of what is now Amber Road (e2Open). He is also a venture investor in cancer research and AI-driven finance technologies.

Jay Crowley is currently Vice President, Medical Device Solutions and Services, and UDI Practice Lead at USDM Life Sciences. Prior to joining the firm in January 2014, Jay was Senior Advisor for Patient Safety at the FDA’s Center for Devices and Radiological Health.  He held a variety of positions over his nearly 27 years at FDA.  Jay had primary responsibility for the development and implementation of the US FDA’s Unique Device Identification System Regulation and the accompanying database (GUDID), as well as the development of the GHTF and IMDRF UDI guidance documents.  Jay supports a wide variety of stakeholders in the development and implementation of UDI and UDI data, including manufacturers, providers, and governments.