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
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
The original documents are held in my private record and can be shared on request.