Developing Software as a Medical Device (SaMD) requires more than robust software engineering—it demands documentation that demonstrates safety, quality, and regulatory compliance throughout the product lifecycle.
Join Venture Center's Regulatory Information and Facilitation Center (RIFC) for an online awareness session on "Understanding Documentation Requirements as per IEC 62304 for SaMDs." This session will provide participants with a practical understanding of the documentation expected under the internationally recognized IEC 62304 standard and how it supports successful regulatory submissions.
Whether you are building a new SaMD solution or developing software-enabled medical devices, this session will help you understand how to establish documentation practices that are structured, compliant, and audit-ready.
Date : 20 August, 2026
Time : 11.00 am -12.00 pm
Mode : Online
Participants will gain insights into :
This session is designed for:
Akash Dhade is part of the Regulatory Information and Facilitation Center (RIFC) at Venture Center, where he supports organizations in identifying appropriate regulatory pathways, preparing technical documentation, and facilitating submissions to notified bodies across the Indian, US, and European markets.
He has contributed to the preparation of technical documentation for more than 20 medical devices, including Software as a Medical Device (SaMD), and is a certified Lead Auditor for ISO 13485 Quality Management Systems through the BSI Academy. His work focuses on helping MedTech innovators navigate regulatory requirements efficiently while strengthening documentation and quality systems.
Aishwaya Varpe | +91 91564 65137 | aishwarya.varpe@venturecenter.co.in
DESCRIPTION:Developing Software as a Medical Device (SaMD) requires more than robust software engineering—it demands documentation that demonstrates safety, quality, and regulatory compliance throughout the product lifecycle. Join Venture Center's Regulatory Information and Facilitation Center (RIFC) for an online awareness session on "Understanding Documentation Requirements as per IEC 62304 for SaMDs." This session will provide participants with a practical understanding of the documentation expect... LAST-MODIFIED:20260810T123423Z LOCATION:Online ... SEQUENCE:0 STATUS:CONFIRMED SUMMARY:Effective documentation is at the heart of every successful Software as a Medical Device. This awareness talk explores the IEC 62304 documentation framework, helping innovators understand what regulators expect and how to establish documentation practices that support compliance throughout the software lifecycle. TRANSP:OPAQUE END:VEVENT END:VCALENDAR