Know your regulator
The third question is what the agency will require of you, and it is the one that decides how long you wait. Reading the rules, deciding what they demand of this particular change, finding the evidence, writing the document, and keeping a trace an auditor can follow. That work is structured, repetitive and expensive, and almost none of it is automated today.
THE SHAPE OF THE WORK
Five steps, each one automatable.
Every expert task in a regulated function decomposes the same way. Naming the steps is what makes them tractable.
Read the rules
Encode what the regulation actually requires, at the level of the specific change in front of you, not the level of the chapter heading.
Triage the change
Decide what this change triggers. Most changes need no submission at all, and proving which is the part that takes an expert a day.
Assemble the evidence
Derive what the chosen path demands, match it against what the organization already holds, and return the delta rather than a checklist.
Author the document
Write it with each sentence mapped to the rule, the risk and the evidence behind it, so the citation is a byproduct of drafting.
Keep the trace
The audit trail is the same artifact as the work, not a reconstruction of it assembled the week before an inspection.
A person decides
The engine reads, derives and drafts. The judgment, and the signature, stay with the professional who carries the liability.
TRIAGE, IN ONE PICTURE
Most changes do not need a submission. Proving which is the work.
Every product change raises three questions at once: what are you now claiming, what were you already cleared for, and what evidence do you hold. Where a change lands against those three is the decision, and the branches of a change-assessment tree are just the regions of that overlap.
No submission Letter to file
Nothing. Document the rationale and ship.
No submission Inside the PCCP envelope
Validation on the modified algorithm. The claim is covered; the evidence is not.
Submission required New 510(k)
Nothing, evidence-wise. The claim sits outside what was cleared.
Submission required New 510(k) or De Novo
A pivotal study. New intended use, new burden, no evidence held.
Where a change lands is the decision. The tree is the regions of this overlap.
The expensive mistakes sit at the edges: a change assumed to be inside the envelope that was not, or a submission filed for something a letter to file would have covered.
WHERE WE RUN IT
Regulatory work is the hardest version of this.
We built the engine against the task with the least tolerance for a wrong answer. That is why it is the deepest deployment, not the only shape the work takes.
Regulatory strategy
Classification, pathway, change assessment, competitor precedent and the evidence each path demands, constructed before anything is written. For regulatory affairs, clinical, quality and reimbursement teams.
Submissions builder
Authoring and traceability as one act. Each sentence mapped to the regulation, risk and evidence behind it as it is written.
Have a task your experts do the same way every time?
Walk us through how one of your people does it today. That walkthrough is what we encode.