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01Documents

All the control. None of the authoring.

Every compliance decision your team makes — the plan, the approach, each paragraph — drives your documents automatically. Your regulatory expertise is encoded once and reflected everywhere.

From guidance to signed paragraph — step by step.

The system identifies applicable guidance and presents an implementation plan for each requirement. Your team approves the approach. Paragraphs assemble and queue for review. Each decision draws on previous ones — and feeds every document that depends on it.

/workspace
Approved

You approve. The system writes.

Your role shifts from authoring to deciding. The system handles the writing.

D-042DecisionMDR §10.4ISO §7.3FDA §820

Decisions reused across requirements

New requirements draw on decisions already approved. You never answer the same question twice.

§3.1
§3.2
§3.4

Paragraph-level review

Sign off on paragraphs as they assemble — not 200-page documents at the end.

D-042
SRS-002
RISK-012
PROC-008

One approval, many documents

Each decision populates every document that depends on it, simultaneously.

One source of truth. Every document stays consistent.

Abbreviations, applicability, cross-references, product data, tables — all live at source, surfaced wherever needed. When the data changes, documents are already synced.

IFUInstructions for Use
QM-001 §4.2
IFU-003 §1
RISK-012 §6

No abbreviation lists to maintain

Defined once, enforced consistently across every document automatically.

Device classIIa / SoftwareIEC 62304Applicable

Applicability always justified

Determinations connect to the product data that supports them. Product changes, they update.

SRS-002 · sourceTEST-047 · target

Cross-references that self-check

Connected to content, not text. When referenced content changes, the link flags it.

Traceability matrix
ReqTrace statusDoc
§7.3.3
Traced
SRS-002
MDR I §10
Traced
RISK-012
§7.5.9
Traced
PROC-008

Tables generated, not exported

Compliance tables, traceability matrices — live from your system data, always current.

See documents in action.

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