Steve leads ABHI’s regulatory policy for IVDs and digital health, representing members with the MHRA and IMDRF to drive global regulatory convergence. He brings over two decades of experience from the MHRA, where he also chaired the European Commission’s IVD working group during the development of the IVDR.

Mélanie is the regulatory head of medical devices EMEA and EU MDR PRRC at Bayer Radiology. Holding a pharmacy degree alongside key regulatory experience from Medtronic and Sanofi, she currently leads Bayer’s EMEA radiology portfolio and the setup for their new cell and gene therapy devices.

With 16 years of NHS experience as a cardiac clinical physiologist, Richard joined BSI in 2018, where he is now head of clinical compliance. He is also involved in EU Medical Device Coordination Group (MDCG) working groups.

Alex is head of notified body IVD at BSI. As a bioprocess engineer, he brings over 12 years of notified body leadership from DEKRA and KEMA, complemented by extensive QA/RA industry experience and four years as a regulatory consultant.

Handan governs global quality processes and digital systems, including the Veeva Quality Platform, across the full product lifecycle. She joined Coloplast in 2014 and has held key leadership positions at both HQ and manufacturing sites, specializing in scaling quality capabilities that simplify compliance.

Sandra leads initiatives in regulatory intelligence, digital transformation, and CMC strategy at Cytiva. She brings over 25 years of experience in QA/RA and specializes in global regulatory frameworks and digital enablement like Veeva RIM to accelerate submissions and drive compliant, data-driven ecosystems.

With more than 13 years in the IVD industry, Tom now serves as IVDR/IVD International Manager at GMED and Secretary of the NBCG-Med executive committee. His background includes over 5 years of notified body experience, featuring multiple leadership roles.

Rob leads the MHRA’s innovative devices team, driving the reform of the UK’s medical device regulations as deputy director. He draws on five years of regulatory policy experience at the office for life sciences and a background leading the national physical laboratory’s biometrology group.

Arne brings over 15 years of clinical research and medtech experience to his role as global clinical affairs director at Mölnlycke. With a background in biophysics, he specializes in generating strategic clinical evidence in wound care to drive market access and patient impact.

Jos leads the claims program at Philips, driving the enterprise deployment of Veeva PromoMats. Leveraging his medtech innovation background, he collaborates across commercial, regulatory, and IT functions to scale compliant, AI-enabled content and global localization.

With 20 years of medtech experience, John leads global clinical evidence generation at Teleflex. He specializes in international clinical programs and RWE for FDA/MDR approvals, combining scientific rigor with a strategic mindset to drive global market adoption.

Irene is a biologist with more than 16 years of experience in clinical research, specializing in digital systems that support clinical study operations. She works closely with cross‑functional teams to streamline processes, enhance data quality, and ensure Terumo’s platforms meet scientific and operational needs. Irene is passionate about improving the efficiency and impact of clinical studies through technology, collaboration, and continuous improvement.

Emiliano leads post-market surveillance strategy, vigilance, and IVDR regulatory intelligence at Tosoh Bioscience – Diagnostics EMEA. He also chairs MedTech Europe’s IVD PMS & vigilance working group, drawing on deep expertise in PMS, PSURs, EUDAMED readiness, and QMS integration to align regulators, notified bodies, and industry on practical EU compliance.