How we think about the problem.
Notes on knowledge, evidence, and modernization in regulated MedTech — the questions a CIO and a VP Quality are actually wrestling with.
QMSR is live. The first inspection cycle is the story now.
The rule is in force and QSIT is gone. The systems that get examined are exactly the ones nobody can fully explain.
Your AI can read the code. It can't read the person who wrote it.
A model tells you what a system does. The why — the workaround, the exception, the judgment call — lives in a person.
M&A leaves you the systems — not the people who understood them.
Orphaned applications and a running TSA clock. The knowledge disperses before the documentation ever catches up.
"Tribal knowledge" is no longer a valid defense against a 483.
What used to live safely in an engineer's head is now inside the inspection scope. Demonstrable beats remembered.
You can't sign a value-based contract you can't compute.
When pricing and rebate logic lives in one analyst's spreadsheet, the outcomes-linked deal is a risk, not an asset.
Retrospective validation is off the table. So demonstrate it prospectively.
You can't retroactively bless an undocumented validated system. You have to be able to show what it does, today.
Bring us the system nobody can explain.
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