Where it started
A medtech company with 60 development engineers and a QA/RA team of four. Questions about ISO 11608, IEC 62366-1 and ISO 14971 went to QA by email. The average wait was three days, the answers were rarely reused, and the same questions came back with every new project.
The strategic question
Could an AI standards advisor answer the standards questions with traceable sources, without QA losing control of what the company commits to?
What we found
Six months of questions were sorted. About 40 % had a clear, documented answer in the standards and the company’s own procedures. About 35 % were ambiguous and needed QA’s judgement. The rest were not standards questions at all.
That split became the design. Where the answer is documented, the engineer uses it directly, with a trace to the source. Where it is ambiguous, the answer is provisional until a QA/RA person has signed it off, and everyone involved is notified automatically. The advisor runs in the company’s Microsoft 365 environment with Copilot, so the data stays inside that environment.