Operating Theory · Sep 10, 2026
Continuous traceability instead of reconstruction
The chain from clinical need to post-market observation should be current every day, not rebuilt in the weeks before a submission or an audit. Reconstruction is where the errors enter.
Under the pillar Consumer tech for medical grade devices
The claim
Traceability reconstructed after the fact is a description of what a team wishes it had done. Traceability maintained continuously is a description of what it did. Both produce a matrix; only one of them is evidence.
The chain has ten links: clinical need, product requirement, technical design, hazard, mitigation, verification test, validation evidence, regulatory claim, submission evidence, post-market observation. A break anywhere means a requirement with no test, a hazard with no mitigation, or a claim with nothing under it.
What has to be true for it to work
The links have to be created by the work rather than typed in afterwards: a test that runs updates the verification link, a design change flags the hazards it touches, a complaint attaches to the requirement it concerns. If maintaining the chain is a separate job, it will fall behind, and a chain that is behind is worse than no chain because it is trusted.
The measure we intend to hold ourselves to: at any moment, without notice, the current state of every link should be producible. If preparing that takes a week, the theory failed.
Post-market is part of the chain, not an epilogue
Adverse events, complaints, and recalls are public for the whole industry, and they are the closest thing to ground truth about how devices fail in use. Reading them for a category before designing in it is cheap. Feeding your own back into the risk file is the part most teams do slowly.