As software continues to play an increasingly critical role in healthcare, understanding how to identify, assess, and mitigate risks throughout the product lifecycle has become essential for innovators, developers, and regulatory professionals.
Venture Center invites you to a focused training session on Risk Management for Software as a Medical Device (SaMD), designed to provide practical insights into regulatory expectations, risk management frameworks, and compliance best practices for software-driven medical technologies.
Date : 13 June, 2026
Time : 9:30 AM – 1:00 PM
Mode: Hybrid (In-Person at Venture Center, Pune or Online via Zoom)
Registration Fee : ₹500
Session Highlights :
The session will be led by Anand Paropkari, a seasoned medical device professional with over 20 years of experience in medical device design, quality management systems, and regulatory compliance. Anand has extensive expertise in integrating agile software development practices with stringent regulatory requirements, including FDA 21 CFR Part 820/11, ISO 13485, IEC 62304, HIPAA, and GDPR
Participants will gain hands-on understanding of :
- SaMD classification and risk management fundamentals
- Risk management processes aligned with ISO 14971
- SaMD-specific risk controls and verification approaches
- Post-market surveillance and residual risk management
- Practical exercises and real-world implementation considerations
Who Should Attend :
- Medical device and digital health startups
- Software developers working on healthcare products
- Quality and regulatory affairs professionals
- Product managers and innovation teams
- Researchers and entrepreneurs developing SaMD solutions
Whether you are building a new software-based medical product or strengthening your regulatory and quality systems, this session will provide actionable insights to help navigate the complexities of SaMD risk management.
For Queries Contact :
Aishwarya Varpe | +91 9156465137 | mailto:aishwarya.varpe@venturecenter.co.in
