Theory
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.
The claim
Claim: hypothesis
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
Claim: recommendation
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
Claim: recommendation
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.