New Generation of SaMDs Innovation, Regulation, and Clinical Trust
31 July , 2026
45 Minutes
Join the Webinar as per Your Time Zone
9 AM PDT | 12 PM EDT | 6 PM CEST | 9:30 PM IST
What is it all about?
Software as a Medical Device is reshaping healthcare, but building the product is only part of the journey. The bigger challenge lies in earning clinician trust, navigating global regulatory expectations, scaling adoption, and balancing innovation with safety and compliance.
This exclusive live panel discussion will bring together SaMD and regulatory experts to explore how companies can build trusted, scalable, and regulation-ready software products for the future of healthcare.
During the panel discussion, our experts will discuss:
- Industry trends shaping the next generation of SaMDs
- Key cultural and operational barriers to clinical adoption
- How investor expectations shift for SaMD startups with long regulatory timelines
- Balancing agile development with medical quality and safety standards
- Navigating global regulatory expectations across the US, Europe, Asia, and other markets
- The role of AI and generative models in building clinical trust
By attending, you will gain practical insights into the future of SaMD innovation, adoption, commercialization, and compliance.
Prashil Panchal heads the global strategy for Software as a Medical Device (SaMD) and Digital Health initiatives at Freyr Solutions. With over eight years of combined experience in Regulatory Affairs (RA) and Quality Assurance (QA) within the medical technology domain, he has developed deep expertise in regulatory strategy, market access, and quality system alignment with global standards such as MDSAP.
Holding a Master’s degree in Regulatory Affairs from the University of Southern California, Prashil has successfully guided multiple organizations in navigating complex regulatory pathways for high-growth medical device and digital health innovations. His work focuses on building compliant, scalable frameworks that enable faster and safer adoption of next-generation healthcare technologies.
Srividya “Sri” is a Regulatory Affairs Specialist at Asahi Intecc and a former clinical dentist who transitioned into U.S. regulatory affairs after earning her MS from Northeastern University. Her work focuses on digital health, connected devices, Software as a Medical Device (SaMD), AI/ML-enabled medical devices, IoT, algorithmic transparency, and real-world performance monitoring.
She is the creator of the TRACE framework Transparent outputs, Representative data, Accountable oversight, Continuous monitoring, and Ethical governance—for trustworthy AI/ML medical software. Sri has published and spoken internationally, including at the ISPE AI in Life Sciences Summit and The MedTech Conference. She also built eguTron, an AI-powered regulatory simulation platform, and Synapsense, an MIT GrandHack 2025-winning AI diagnostic tool for Parkinson’s disease.
Lavanya Ramnath is a regulatory affairs professional with over eight years of experience supporting innovative and breakthrough diabetes, cardiovascular, complex medical device, SaMD, and digital health technologies. Having held progressive regulatory roles at Insulet, Abbott, BD, and MiniMed/Medtronic Diabetes, Lavanya has developed strong expertise in regulatory strategy, global submissions, health authority interactions, and product lifecycle management across pathways such as 510(k), IDE, EU MDR, PMA, and other global submissions.
Holding a Master’s degree in Medical Devices and Diagnostic Engineering from the University of Southern California and a Bachelor’s degree in Biomedical Engineering from the University of Mumbai, Lavanya actively contributes to the regulatory affairs community through RAPS, TOPRA, and the San Diego Regulatory Affairs Network, supporting education, programming, judging, mentoring, and professional leadership.
Panel Host
Prashil Panchal
Global Strategy Head - SaMD and Digital Health, Freyr Solutions
Panelist 1
Dr. Srividya Narayanan
Regulatory Affairs Specialist, Asahi Intecc USA
Panelist 2
Lavanya Ramnath
Regulatory Affairs Professional, Insulet