International MedTech Safety Conference (IMSC26)
Boston, MA, USA
2-5 June 2026
Invited Speaker
Michelle Tarver, M.D., PhD
FDA - Director, Center for Devices and Radiological Health
Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health. She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture. Dr. Tarver has held various leadership positions while at FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement. Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials, and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. Dr. Tarver has extensive policy experience in crafting regulations, guidances, and conducting premarket and postmarket reviews. She most recently served as the Deputy Center Director for Transformation, steering the development, implementation, and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the healthcare ecosystem, and stimulate creative evidence generation pathways. Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health. As a dedicated clinician, she continues to care for people living with inflammatory eye conditions.
Pat Baird
Pat Baird is the Co-chair of the AI committee that created AAMI TIR34971: Application of ISO 14971 to AI/ML Devices. He is also a lead person in the creation of ISO/TS 24971-2, the successor to AAMI TIR34971. He works at Philips as a Sr. Regulatory Specialist, with a focus on the use of AI in healthcare. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, whitepapers, and training to meet those needs. He co-chairs multiple committees related to artificial intelligence, is an industry rep for IMDRF AI committee, and current standards projects include risk management for ML systems and cybersecurity considerations for ML systems.
Susan Neadle
Susan W. Neadle, MS, BS, FRAPS, FAAO, is a recognized international authority in combination products, medical devices and digital health, with over 35 years of industry experience. After retiring from a distinguished 26-year career at Johnson & Johnson in strategic and technical roles, she founded Combination Products Consulting Services LLC, where she leverages her extensive expertise to provide strategy, quality, regulatory affairs, and technical design excellence services to the bio/pharma, biotech and medical device industries. Susan chairs the AAMI Combination Products Steering Committee and plays leading roles in numerous industry-working groups, including Combination Products Coalition, ISPE, TOPRA, AFDO/RAPS and MediPhorum. She is also a respected educator, teaching combination products, integrated risk management, and quality system curricula through her consulting business and at UMBC, AAMI, and DIA, among others. Her significant contributions to the industry have earned her several prestigious awards, including Fellowships in the Regulatory Affairs Professional Society and American Academy of Optometry, 2022 ISPE Joseph X. Philips Professional Achievement Award, 2021 TOPRA Finalist in the Futures category for Regulatory Excellence, and the Johnson Medal for Research & Development Excellence from Johnson & Johnson. In 2023, Susan published “The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems,” through Taylor & Francis/ CRC Press. This comprehensive guide provides helpful information and best practices on combination product lifecycle from pre-market development and regulatory pathways, through post-market, making it an essential resource for professionals in the field. Through her consultancy and active participation across industry forums, presentations and workshops at numerous venues, and authorship of chapters, books, whitepapers, and technical standards, Susan continues to advance the field, driving innovation and leading critical conversations in the industry.
Michelle Jump
Abstract
Michelle L. Jump is the CEO of MedSec, LLC, where she leads a team of experts focused on regulatory strategy and technical analysis of cybersecurity for medical devices. With over 15 years of experience across the MedTech sector, she is a recognized leader in digital health, regulatory compliance, and product security. Michelle has held senior roles at Stryker, Carestream Health, and Nova Leah, where she developed global regulatory programs and advanced industry-wide cybersecurity initiatives. She has contributed to international standards through her work with AAMI, ISO, IEC, UL, IEEE, and IMDRF, and regularly speaks at global conferences and FDA workshops. She holds an M.S. in Regulatory Science from USC, an M.S. in Biotechnology, and a B.S. in Biology from UC Santa Barbara. Michelle is RAC certified and a Certified HIPAA Administrator.
John Thomas, PhD
Dr. John P. Thomas is Co-Director of the Engineering Systems Laboratory (ESL) in MIT’s Department of Aeronautics and Astronautics. His work centers on developing and applying systems-theoretic safety methods for complex systems. He leads research that bridges aerospace, automotive, and healthcare domains. Dr. Thomas’s research integrates model-based approaches to safety, requirements development, and analyzing human–system interactions for critical applications ranging from autonomous flight to healthcare technology infrastructure. In the healthcare sector, his work has pioneered modern approaches for ensuring safety of medical-devices, diagnostic laboratory systems, and other equipment in healthcare. His recent collaborations include an FDA study on Safety of Laboratory Data Exchanges, IVD Devices, over-the-counter (OTC) and point-of-care (POC) diagnostic systems, and other healthcare equipment.
Stay Tuned for Our Other Distinguished Speakers
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