
Mastering Your SRS Template for Medical Software
This lesson from Yale's Introduction to Medical Software course walks through the System Requirement Specification (SRS) template used in medical software development. The instructor moves section by section, from the cover page through functional and non-functional requirements, showing how to draft requirements that are testable and properly scoped. Particular attention goes to two sections often skipped over: the significance section, which justifies why a requirement matters, and the intended use section, which the lecture ties directly to regulatory clearance, explaining how a change in intended use can force a device or software product back through review. The lecture is aimed at students building or documenting medical software and treats the SRS as a working engineering document rather than paperwork, with concrete guidance on wording and abstraction level for individual requirements.