Understanding FDA’s Documentation Requirements for Software as Medical Device (SaMD)
Followed by one-on-one Mentoring session | 30 mins per slot | Selected 5 Slots
What to expect:
- Overview of SaMD and FDA Regulatory Pathways
- Key Documentation Required for SaMD Submissions
- Software Development Life Cycle (SDLC) and IEC 62304 Alignment
- Best Practices for Submission and FDA Interactions
Speaker: Mr. Akash Dhade (Associate Manager – Regulatory Services)
For more information contact
Aishwarya Varpe | aishwarya.varpe@venturecenter.co.in | 9156465137
