Dr. Hans-Martin von Stockhausen is a Principal Key Expert for Cybersecurity at Siemens Healthineers. With over 25 years of experience in the medical device industry and a background in medical informatics, he has gained extensive domain knowledge throughout the product lifecycle. Since more than a decade, Dr. von Stockhausen has focused on product security, holding various positions such as a member of the Siemens-wide product and solution security board, business line product security officer, senior product manager, and recently starting as customer advocate.

As a member of the corporate cybersecurity governance organization, he is dedicated to improving and maintaining the security posture of products, the quality of vulnerability management processes, and security-related customer communication. Dr. von Stockhausen participates in expert workshops and talks at conferences held by European and internationally recognized organizations. He is a member of the board of directors of the Health-ISAC.

As Clinical Systems & Medical Data Lead at Stryker, Sepanta Fazaeli drives T&E and enterprise-wide AI and data transformation efforts, with a focus on system-level integration, intelligent automation, and digital readiness. He leads strategic initiatives that modernize evidence management and operationalize AI across business units, bridging clinical, regulatory, and technical domains.

With a background in clinical data sciences and deep experience in implementing AI-powered solutions in regulated environments, Sepanta specializes in building scalable, reproducible systems that enable compliant automation in high-stakes domains. His work spans AI strategy, data governance, and enterprise infrastructure, bringing a systems-thinking approach to embedding intelligence where it matters most.

He also represents Stryker on the MedTech Europe AI Act Task Force, a cross-industry working group focused on the evolving regulatory landscape for AI-enabled medical devices. In this role, he contributes to collective industry responses, helping to interpret and shape the implementation of the EU AI Act in ways that safeguard patient safety while enabling innovation. His involvement emphasizes the need for clear, practical, and risk-based approaches to AI regulation in the MedTech sector.

Alice has worked as a Senior Research Executive in the Post Market Clinical Follow Up (PMCF) team at Purdie Pascoe, specialising in PMCF surveys for medical devices, since the start of 2023. She works with manufacturers across a range of device types and risk classifications to successfully plan, design and implement both Level 4 (high quality) and Level 8 (general usability) PMCF surveys.

Chris joined Purdie Pascoe in 2019 with a BSc in Biochemistry and Molecular Medicine from the University of Nottingham. Since then, Chris has progressed to become a PMCF Manager. He leads on projects to assist a wide range of medical device manufacturers in the design, implementation, and analysis of PMCF surveys. Over the last 5 years Chris has gained experience in all aspects of the PMCF survey process and has worked with both high quality (level 4) and general usability surveys (level 8) over a range of device types and risk classifications.

Frank Matzek served as the Vice President Regulatory & Governmental Affairs at BIOTRONIK in Berlin, Germany. BIOTRONIK is a leading global medical device com­pany with products and services that save and improve the lives of patients suffering from cardiovascular and endovascular diseases.

Frank holds a Dipl.-Ing. degree in biomedical engineering from the Technical Univer­sity of Berlin, is a certified quality engineer and has received a degree in business and administration from VWA Berlin.

In addition to his role with BIOTRONIK, Frank was actively involved in the industry associations MedTech Europe and BVMed Germany as a member/vice-chair of various core teams, work groups and committees.

Jacob Barkai is a Distinguished Product Security Architect at Edwards Lifesciences, with over two decades of experience in software engineering and cybersecurity.

Specializing in medical device security, Jacob leads technical initiatives at the intersection of AI, safety, and secure design.

Adam Gregory currently leads the Regulatory Affairs team focused on Advanced Wound and Skin Care products in Coloplast A/S bringing positive change to patients where we work to make life easier for people living with wounds and the healthcare professionals who treat them. Adam has spent the last 8 years in Regulatory Affairs within the global medical device industry, with a specific focus on Rule 14 combination products from Advanced Wound Care and animal derived implantable devices and is keen to promote discourse on combination products to bring about positive industry changes.

Software and hardware engineer and technical lead with 16 years of experience within medical device development. Worked on active implantable devices, combination products, and safety-critical software. Currently at InnoCon Medical, responsible for hardware and software and related processes.

InnoCon Medical have developed UCon, a partially implantable neuromodulation system, that relieves symptoms of incontinence. 

With over 15 years of experience in Product Quality Engineering for Medical Devices, Harsh Jain specializes in a broad array of technologies including Lab Analyzers, Arthroscopic Instruments, Tissue Ablation, Blood Management SaMD, Sequencing Technologies, Digital Health, Cardiac Wearables, and Orthodontic Devices.

He possesses extensive knowledge of the Medical Device Development Life Cycle (both software and hardware), Risk Management (including Product and Cybersecurity), and a strong understanding of US and International Regulatory Standards.

He is skilled at developing Quality Strategy Roadmaps for innovative and complex medical devices, ensuring that they meet compliance requirements, function reliably, and perform optimally in highly regulated environments. Education: MBA in Life Sciences, Master’s in Regulatory Affairs in Medical Devices, Master’s in Computer Science, Undergraduate degree in Mechanical Engineering.

Helena Neves is a Regulatory Affairs Specialist at 3Shape working with AI-enabled Software as Medical Device (SaMD). Responsible for supporting development teams across the full lifecycle of AI medical device development—from data governance and model validation to navigating global regulatory frameworks. Their recent work includes aligning AI development with the EU AI Act, MDR, and newest FDA Guidelines.