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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.

Christy has 25+ years of experience across the pharmaceutical and medical device industries in sponsor and CRO settings. For nearly five years, she has partnered with ³Ô¹Ï±¬ÁÏ and leads a team of clinical data managers and database programmers supporting multiple BD business units. Christy delivers end-to-end data management—from study start-up through database lock—by championing interoperable workflows (EDC, eCOA, CDB) that reduce burden, accelerate insights, and strengthen compliance.

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 ³Ô¹Ï±¬ÁÏ 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 ³Ô¹Ï±¬ÁÏ RIM to accelerate submissions and drive compliant, data-driven ecosystems.

Blake leads strategic commercial initiatives across CRM transformation, data management, customer engagement, and field enablement EMEA. By aligning business strategy with technology, he focuses on balancing rapid value delivery with long-term capability building to drive measurable growth. Previously, Blake led commercial strategy and technology initiatives for medtech organizations at ZS.

Alongside his role at DNV Product Assurance, Alex serves as President of Team-NB, the European Association of Notified Bodies for medical devices. He brings over 13 years of notified body experience, building on his previous career in medical research and pediatric surgery.

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.

Becki leads regulatory affairs initiatives for advertising and promotion at Medtronic. She also focuses on modernizing promotional review workflows and scaling digital solutions across highly regulated environments.

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.

Brian modernizes global operations at Novocure across clinical, safety, supply chain, quality, and regulatory. He specializes in platform-based strategies that reduce complexity, scale workflows, and align technology solutions with broader business goals.

Jos leads the claims program at Philips, driving the enterprise deployment of ³Ô¹Ï±¬ÁÏ PromoMats. Leveraging his medtech innovation background, he collaborates across commercial, regulatory, and IT functions to scale compliant, AI-enabled content and global localization.

With 15 years of quality and regulatory experience, Markus is an expert in data-driven post-market surveillance and European regulatory compliance. He chairs MedTech Europe’s PMS & vigilance working group, contributes to MDCG task forces, and is a recipient of the 2026 RAPS 50for50 regulatory trailblazer award.

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.

With over 25 years of quality and regulatory experience, Koen manages medical device and CDMO plants, driving operational excellence through practical, compliant, and locally adaptable processes. As a bio-engineer, he bridges global standards with local site needs to empower high-performing, cross-functional teams.

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.