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.
Event Details :
Date : 20 August, 2026
Time : 11.00 am -12.00 pm
Mode : Online
What You Will Learn :
Participants will gain insights into :
- The documentation framework prescribed under IEC 62304, including the key documents generated across the software development lifecycle—from planning and software requirements to verification, release, and maintenance.
- The role of documentation in demonstrating regulatory compliance, including software safety classification, risk management, traceability, configuration management, and quality assurance.
- Practical strategies for preparing robust, audit-ready documentation while avoiding common gaps and deficiencies identified during regulatory assessments and quality audits.
Who Should Attend?
This session is designed for:
- Developers and software engineers working on Software as a Medical Device (SaMD)
- MedTech and Digital Health startups
- Medical device manufacturers developing software-enabled medical devices
- Regulatory, quality assurance, and product development professionals involved in medical device software
Speaker in Focus : Akash Dhade
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.
For Queries please contact :
Aishwaya Varpe | +91 91564 65137 | aishwarya.varpe@venturecenter.co.in
