Built an AI agent for regulated requirements
I built an AI agent that takes requirements from ambiguous to reviewable and checks them against IEC 62304 and FDA guidance, then presented it to the software technical advisory board.
- AI
- Quality
Responsible AI ยท regulated medical softwarePart of my work on digital transformation in regulated software and systems development, through the responsible use of AI.
What would have happened
Requirement gaps would surface late in reviews and audits.
The call
Keep a person deciding; let the agent point to evidence.
What I did
Built the agent and its analysis prompts, and presented it to the software technical advisory board.
What changed
Other teams requested access; it later became an official asset of the company's AI platform.
Proof
