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From Concept to Care:
Harnessing Software as a Medical Device
Thursday, May 22, 2025
Event Starts: 4:30pm
Location: Dartmouth Hitchcock Medical Center, Auditorium E, 1 Medical Center Dr, Lebanon, NH 03766
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Innovating with Software as a Medical Device
Explore the rapidly evolving world of Software as a Medical Device (SaMD) in this focused event designed for innovators, regulators, and industry leaders. As software continues to redefine the boundaries of healthcare, this session will dive into key topics such as regulatory pathways, clinical validation, cybersecurity, and the integration of AI/ML technologies.
Attendees will hear real-world insights from experts who have successfully navigated the SaMD development lifecycle—from concept to commercialization. Whether you're building your first SaMD product or looking to refine your go-to-market strategy, this event offers valuable guidance on staying compliant, competitive, and ahead of the curve.
Learn About the Panelists:
Bill Greenrose
Regulatory & Quality Consultant, William Greenrose Consulting
Bill is a Regulatory and Quality Consultant with over 42 years of experience (23 in industry) in global Life Science regulatory compliance. At Deloitte & Touche he served as Managing Director of the Advisory Regulatory and Quality Transformation practice, where he assisted clients in the areas of quality assurance (21CFR820, 21CFR11, ISO 13485, etc.), Software as a Medical Device (SaMD), Digital Health Technology (DHT) quality control processes, compliance, regulatory strategy & submissions (510(k), Technical File, etc.), IT, clinical laboratory/CLIA, R&D, manufacturing, core lab, reimbursement and corporate/operations. He helps clients in developing strategies for compliance with evolving regulatory requirements, especially as they relate to new product development and launch in multiple local markets, quality system and organizational builds, optimizations and remediations, labeling controls, post market surveillance (e.g., PV, MDR, AE reporting from alternative sources, such as social media), auditing and training in a highly regulated environment. He has written articles on new regulations, such as the impact of COVID on global medical product regulations, EU MDR, MDSAP, ISO 13485 and ISO 14971.
Pradeep Bokinala
Chief Technology Officer, Simbex
Pradeep Bokinala is a seasoned product leader with over 20 years of experience driving innovation across healthcare, sports technology, mapping, and enterprise applications. He has successfully led numerous wearable technology initiatives from concept to launch, with deep expertise in wearables, IoT, SaaS, and data analytics. Passionate about agile development, Pradeep thrives on iterative processes and rapid feedback loops, breaking down complex visions into actionable sprints that deliver incremental value. Before joining Simbex, he held leadership roles at TomTom and Dartmouth Health, where he focused on building high-performing, sustainable teams. With international experience in India and Amsterdam, Pradeep combines a global perspective with a hands-on approach to product and team development. He holds a Master’s in Software Applications from Nagarjuna University and an MBA in Leadership from Franklin Pierce University.
