Dezi-Q
Medical device design control workspace
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Design controls, traceability, and audit readiness

Know what is ready, what is missing, and what would fail review.

Dezi-Q helps medical device teams manage linked design-control records, phase readiness, document instances, AI review, and controlled exports without replacing the rest of the QMS.

Use it as the execution workspace where teams clean up traceability, prepare review packages, and hand released records to the validated repository.

Project Health Health score, guided workflows, stale records, and audit blockers in one view.
Traceability Intelligence Missing links, orphan records, weak rationale, duplicates, and uncovered hazards.
Phase Review Workflow Checklist progress, phase gates, approvals, reviewer disposition, and history.
AI Audit Reviewer Ask what would fail an audit, summarize changes, and review weak records.
Product Preview Limited preview. Request a demo for full platform access.

Watch the Dezi-Q workflow in motion

See project setup, linked traceability, change impact review, and controlled export flow in one guided pass.

See the Dezi-Q workspace structure

Projects, phase readiness, linked records, and change history stay visible inside one review-oriented workspace.

Dezi-Q Workspace Revision-aware design controls
Project Creation
Phase Tracker
Traceability Matrix
Export Control
Linkages Reqs, hazards, mitigations, and FMEAs stay connected.
Concurrency Active editor visibility and row-level lock control.
Audit trail Revision history and final export baselines are preserved.
6 phases organized
24 linked entries
Rev B current final baseline

Traceability snapshot

Control linked records, active editors, and review-ready exports in one place.

REQ-1-004 Linked to SPC-1-002, HZ-1-011
Battery runtime shall support 12 hours Low
HZ-1-011 Locked by Riley Chen
Missed posture alert during use Locked
DFMEA-1-006 Feeds final export Rev B
Sensor drift analyzed with mitigation Low
SPC-1-002 Referenced by REQ-1-004 and DFMEA-1-006
Charging dock output remains within tolerance Medium

Recent change history

03/16/2026 9:42 AM
REQ-1-004 edited. Linked hazard and specification references preserved.
03/15/2026 4:18 PM
Specifications 1 exported as Rev B with changes since the previous final.

Preview revision-control Word output

Draft, final, and reference exports carry revision metadata, change-control context, and evidence-ready table output.

Company Northstar Rehab Labs Design Controls Program

Requirements Traceability Matrix

Final release package showing controlled revision status, linked evidence, and change history since the last approved export.

Revision Rev B Final Effective: 03/16/2026
Change Control Summary
Record ID CR-2026-014
Approval Approved for release after linked specification and hazard review.
Impact Requirements, hazard analysis, and verification references updated together.
Revision Delta
Rev A -> Rev B
REQ-1-004 Runtime acceptance text revised from 10 hours to 12 hours after verification result DVT-104 was approved.
SPC-1-002 Dock output tolerance reference added to align the exported specification with the released charging requirement.
HZ-1-011 Residual-risk rationale updated to reflect linked mitigation evidence and the latest low-battery warning validation review.
Exported Table Preview
ID Requirement Linked Evidence Status
REQ-1-004 Battery runtime shall support 12 hours of continuous operation. DVT-104, SPC-1-002, HZ-1-011 Released
REQ-1-006 Low-battery warning shall trigger 60 minutes before shutdown. DVT-108, DFMEA-1-006 Released

Traceability matrix at a glance

Visualize how needs, requirements, specifications, mitigations, hazards, and FMEAs connect across phases in one map.

Dezi AI Agent for project-scoped review

Ask project questions, draft new IDs, review likely links, and assist imports while keeping the organization's own provider key and project boundary in place.

Dezi AI Agent
Org-owned OpenAI or Claude
Ask
Which requirements are missing verification coverage?
Project-scoped answer

Dezi reviews only the active project context, highlights the linked gaps it finds, and keeps the answer separate from controlled records.

Ask Dezi Draft New ID Link Suggestions Import Assistant
Private by design Organization-owned provider key, project-scoped context, review-first output.

Use the carousel controls to preview the demo video, workspace, revision-control export example, traceability matrix, and Dezi AI Agent.

Use Case

For active design-control work

Dezi-Q is where teams build, review, and clean up design-control evidence before final records move into the customer's existing QMS or document repository.

  • Teams preparing design reviews, phase exits, and audit packages.
  • Consultants turning scattered project data into reusable structure.
  • Startups that need traceability discipline before a full eQMS rollout.
Workflow

One place to find the next action

  • Open Project Health to see readiness, traceability, stale records, and audit blockers.
  • Use guided workflows to start Phase 1, prepare design review, or build an audit package.
  • Use filtered worklists to fix links, rationale, orphan records, and coverage gaps.
  • Export draft, final, or reference packages when the evidence is ready.
Current Features

What Dezi-Q checks for you

Project Health score Combines phase readiness, trace coverage, phase-gate approval, final export posture, stale records, and reopened items.
Traceability intelligence Flags missing links, orphan records, uncovered hazards, duplicate requirements, weak rationale, and stale active records.
AI review assistant Runs project-scoped review prompts such as audit readiness, weak requirements, missing coverage, and change summaries.
Document manager Creates scoped document instances for subsystems, workstreams, or separate requirement/risk documents without losing traceability.
Execution

How records move toward release

Review and approval workflow Tracks phase checklists, gate status, approval information, reopen reasons, comments, and change history.
Controlled import and export Imports active records through previewed batches and exports draft, final, or reference packages with revision context.
Collaboration controls Shows active editors, row locks, shared revision baselines, and full change history so teams do not overwrite each other.
Standards-aware structure Keeps design inputs, risk records, software records, verification, validation, and post-market feedback organized for regulated work.
About

About Dezi-Q

Dezi-Q is built for medical device teams that need structured design-control execution without replacing the rest of their quality system.

Use it to create, revise, and export controlled deliverables, then hand final records off to your existing repository.

It is designed to make day-to-day design-control work easier to manage while supporting teams working toward compliance with medical device quality and risk standards, including ISO 13485, IEC 62304, ISO 14971, and FDA 21 CFR Part 820.