Solutions · Document Management
Every doc.
Every draft.
Every reviewer.
Writing regulatory documents, tracking revisions, managing reviewer cycles, and locking final approvals — this is where Drafting Studio, Collaboration, and Cloud work as one. The complete regulatory document lifecycle, without the folder chaos.
The document lifecycle
From first draft to locked version — in one workspace.
Phase 01 · Write
Drafting StudioStart writing
- Pick a template or start blank
- AI fills gaps from device profile
- Citations auto-linked as you type
- Inline AI for rewrites & expansion
Phase 02 · Review
CollaborationInvite reviewers
- Assign sections by role
- Threaded comments per paragraph
- Suggested edits with accept/reject
- External consultant access scoped
Phase 03 · Approve
CloudLock and sign off
- Section-level approval workflow
- Version freeze at review milestones
- Electronic sign-off with audit trail
- 21 CFR Part 11-compatible log
Phase 04 · Store
CloudArchive & track
- AES-256 encrypted storage
- Full version history forever
- Retention policies per document type
- Linked to submission & risk file
Document types covered
Every regulatory document your device needs.
Complizen has templates, citation libraries, and AI drafting support for all of these document types — and more.
510(k) Submission PackageInstructions for Use (IFU)Design History File (DHF)Risk Management File (ISO 14971)Verification & Validation ProtocolsSubstantial Equivalence NarrativeIndications for Use StatementDevice DescriptionBiocompatibility EvaluationSoftware Documentation (IEC 62304)Labeling (21 CFR 801)Quality Management System (ISO 13485)SOPsPre-Submission (Q-Sub) PackagePost-Market Surveillance PlanPeriodic Safety Update Reports
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