a note on software as a medical device samd in the u s
PDF · 24 Sept 2025
This Harvard Business School draft note (authors Satish Tadikonda, Harshita Menon, William Marks; dated August 27, 2024) explains Software as a Medical Device (SaMD) in the U.S., covering definitions, FDA/IMDRF risk-classification frameworks, market trends, development and lifecycle practices, cybersecurity and risk management, and future directions including AI/ML integration and autonomous surgery. It is written as a practical primer for firms and students navigating SaMD development and regulation.
Questions this document answers
Satish Tadikonda; Harshita Menon; William Marks.
August 27, 2024.
"software intended to be used for one or more medical purposes without being part of a hardware medical device."
President and Fellows of Harvard College, 2024.