Software as a Medical Device: From Regulatory Strategy to Market Readiness

Join MIDI in this webinar discussion about how bringing Software as a Medical Device (SaMD) to market requires more than developing innovative technology. Regulatory strategy, software development, risk management, and commercialization planning need to work together from the beginning. In this webinar, Gregory Montalbano, Founder of MIDI Medical Product Development, will provide a practical framework for developing SaMD products with regulatory requirements built into the development process rather than addressed after the software has been created.

Attendees will learn how to:

• • Integrate regulatory requirements into software development using FDA expectations, IEC 62304, risk management, cybersecurity, and design controls as part of the development lifecycle.
• • Determine the most appropriate FDA pathway by understanding intended use, device classification, predicates, 510(k), Third Party 510(k) Review, De Novo, and when FDA interaction may be valuable.
• • Create submission-ready documentation as the product evolves, reducing the risk of costly DHF gaps, redevelopment, and delays later in the program. • Connect regulatory strategy with product and business strategy so development, clinical evidence, FDA milestones, funding, and commercialization objectives remain aligned.
• • Reduce regulatory uncertainty early by identifying the decisions that can have the greatest impact on development cost, schedule, and market entry.
• Rather than treating regulatory compliance as a final hurdle before submission, this session will demonstrate how a well-planned regulatory strategy can become an integral part of product development and a powerful tool for reducing risk. Whether you are developing your first SaMD product, preparing for an FDA submission, or refining the strategy for an existing digital health platform, this webinar will provide practical insights for moving from innovation toward commercialization with greater clarity and confidence

Date: Wednesday, September 16, 2026
Time: 12:00 PM – 1:00 PM ET
Location: Online

Meet the Speakers

Gregory Montalbano, Principal & Co-Founder, MIDI Product Developmemt

TBD