Are you a digital health innovator, SaMD startup, product manager, or software engineer navigating the medical device regulatory landscape?
Join us for an insightful workshop on --
This 3-day program sets the context for what modern SaMD compliance really demands. It offers practical guidance across quality, risk, and cybersecurity, all designed to help teams build regulatory-ready, secure, and audit-proof software-based medical devices.
Organized by : RIFC, Social Innovations, and BFI-BIOME Networks
Supported by : Venture Center, Pune and Blockchain for Impact
Date : 6th December 2025
Time : 10:00 AM – 6:00 PM
Mode : Hybrid (In - Person at Venture Center and Online via Zoom)
Fees : ₹ 1000
Key Topics to be covered across three days
Practical cybersecurity controls spanning secure design, secure development, technical and operational safeguards, and post-market security
Tools and technologies for secure development, vulnerability handling, SBOM management, and end-to-end compliance workflows
Harmonizing QMS and ISMS with shared SOPs for access control, risk, incident handling, change management, supplier oversight, and documentation
Hands-on frameworks, including standards-interlink maps, evidence checklists, and software documentation templates
Seats are limited, and allocation will be on a first-come basis.
About the Speaker :
Anand Paropkari is a seasoned medical device and SaMD compliance expert with over two decades of experience spanning IT and product development. He specializes in implementing QMS frameworks aligned with global regulations, including 21 CFR 820/11, ISO 13485, ISO 14971, IEC 62304, and EU-IVDR, along with cybersecurity standards such as ISO 27001, HIPAA, GDPR, SOC, and FedRAMP. Over the years, he has supported a wide range of organizations—startups to large enterprises—in integrating agile development with stringent regulatory requirements. He holds an MS from BITS and a BE from the University of Pune.
For Queries Please Contact ;
Technical Queries : Mr. Akash R. Dhade | akash.dhade@venturecenter.co.in | 9511903743
Registration Queries : Ms. Aishwarya Varpe | aishwarya.varpe@venturecenter.co.in | 9156465137
DESCRIPTION:Are you a digital health innovator, SaMD startup, product manager, or software engineer navigating the medical device regulatory landscape? Join us for an insightful workshop on -- Software as Medical Device (SaMD) for Quality Management System (QMS), Risk Management, and Cybersecurity Management This 3-day program sets the context for what modern SaMD compliance really demands. It offers practical guidance across quality, risk, and cybersecurity, all designed to help teams build regulatory-r... LAST-MODIFIED:20260404T071146Z LOCATION:Hybrid (In -person at Venture Center and Online via Zoom) ... SEQUENCE:0 STATUS:CONFIRMED SUMMARY:Step into a focused 3-day workshop that makes SaMD compliance easier to grasp and apply. You’ll explore how QMS, risk, and cybersecurity come together in real product development and gain a clearer sense of what it takes to build software that’s genuinely ready for regulatory scrutiny. TRANSP:OPAQUE END:VEVENT END:VCALENDAR