The scene
Marketing writes the strongest line. Sales wants it shorter. RA/QA narrows it. Legal asks for a change. The founder becomes the traffic controller.
That is a workflow problem, not only a writing problem.
The wrong frame
The weak fix is rewriting the sentence again. The stronger fix is giving every claim a status, owner, source, and escalation path.
Build the claim workflow
| Field | Use |
|---|---|
| Claim | The exact phrase or message being reviewed. |
| Owner | Who owns review or escalation. |
| Source | Public source, internal source, customer-owned source, or no source yet. |
| Status | Allowed, limited, review-only, unsupported, or do-not-say. |
| Approved wording | The current wording the team may use. |
| Boundary | What the team must not imply. |
The founder-level move
The goal is not weaker marketing. The goal is language that the buyer understands and the review team can live with.
Source ledger
What it can tell you
FDA explains why registration and listing terms can mislead when used like approval, clearance, authorization, or certification.
What it cannot decide
Whether a specific company claim, website phrase, sales script, or distributor email is acceptable.
What it can tell you
FDA explains the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference.
What it cannot decide
A specific company's claim approval workflow, quality-system conformance, labeling decision, or legal review result.
Frequently asked questions
Does this replace legal or RA/QA review?
No. It organizes the review workflow so qualified reviewers can make decisions from visible wording, source notes, status, and boundaries.
What should the first claim workflow include?
A table of claims, source status, owner, allowed wording, limited wording, review-only wording, do-not-say boundaries, and escalation rules.
Need one claim workflow instead of four rewrites?
TrueMedDevice can prepare a first claim-boundary workflow for one product, one page, and one review team.