Work queue · top of the queue
All priority items →| Reg | Citation | Snippet | Verdict | Pri. | Conf. |
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Strengths · top of the QMS
All strengths →| Reg | Citation | What's covered | SOPs | Conf. |
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Regulators · coverage spread
All regulators →—
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Top risks All priority items →
Enforcement headline FDA · US
Top strengths All strengths →
Regulatory intelligence
Cross-Jurisdiction Readiness Take this QMS to a new market
Device Profile & Precedent Classification · De Novo authorizations
By topic Top 8 of 16
By owner QMS roles
See every regulatory finding, in detail
Every clause scored, with rationale, cited QMS documents, recommended remediation, and FDA enforcement context.
High-priority gaps, in order
Gaps, partials and missing items marked high priority. Most exposing first.
Who decided what, and when
Two independent reviewers must sign before a disposition is final, so one signature means it is still open. Signatures cannot be deleted. Reverse a decision by signing a new one.
Every regulation & standard, in one place
Every regulation and standard a run is scored against. Open any instrument to read its clauses.
Device intake
The answers here decide which standards this device is assessed against.
Device profile
Check what your answers say about the device before the standards are worked out.
Standards in scope
Derived from the device profile. Every decision cites the answer behind it.
Design phases
Read from your design and development procedure.
Upload the DHF
Drop the design history file as a folder, a ZIP or individual files.
Assessment register
Every deliverable your plan requires, checked against what is in the DHF.
Design history files
Each assessment is anchored to the QMS validation run it is judged against. Start one from a completed run.
Validation history
Every validation this tenant has run, newest first. Open one for its gap report, or start a new one.
How the model is performing
Which models scored this run, how long it took, and how the verdicts came out.
Your team & access
Invite your people, choose whether they can manage the team or only view, and remove access when someone leaves. Warwick’s consultants are managed separately.
The whole quality system, organized
Every document uploaded here, classified on intake and grouped by type: SOPs, work instructions, the quality manual, forms, plans and reference standards. Open any to read it.
Where the QMS reads strong
Compliant verdicts, ranked by confidence and by how many SOPs back them.
Findings grouped by source SOP
Each SOP with the clauses it touches. Strengths first, then findings by severity.
Findings grouped by accountable role
Each role with the clauses it owns. Strengths first, then findings by severity.
Every regulatory clause, scored
Every verdict with its rationale, cited SOPs, remediation and FDA enforcement context. Filter by status or jurisdiction.
These clauses were correctly identified by the engine as not imposing direct manufacturer QMS obligations. They are non-normative regulatory text (recitals, definitions, scoping provisions, routing rules, or obligations addressed to the European Commission, Member States, or competent authorities) rather than to medical-device manufacturers.
They are intentionally excluded from the readiness score so the engine neither penalises nor credits the QMS for clauses no manufacturer can act on. Click any row to see the verbatim text and the engine's reasoning.
