AI-assisted design controls and traceability for medical device teams

Build audit-ready medical devices from day one.

Dezi-Q helps medical device teams organize design inputs, risks, requirements, traceability, and review evidence so projects stay inspection-ready without replacing their existing QMS. Use it as the working layer between messy project documents and final controlled QMS records.

Built by medical device quality professionals.

Request a Demo Watch the 2-Minute Workspace Demo

Dezi-Q Workspace Demo Lite Watch the short workspace demo, then request an in-depth demo.

Watch the Dezi-Q workflow in motion

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

See the Dezi-Q workspace structure

Keep project records, links, review status, and change history visible in one workspace.

Dezi-Q Workspace Revision-aware design controls

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.

AI review for audit-ready traceability

Use organization-owned AI features to find weak rationale, missing links, likely coverage gaps, and review-ready next steps inside the active project boundary.

AI Review

Org-owned AI Features

Ask

What would fail an audit in this project?

Review board

Coverage gaps

Flags records missing required verification, validation, or hazard links.

Weak rationale

Calls out vague evidence, circular reasoning, and stale justifications.

Review summary

Summarizes what changed since the last review and what needs signoff.

Ask Dezi Audit Readiness Trace Review Evidence Check

Review-first by design AI output stays separate from controlled records until a user reviews and accepts it.

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Project Health Health score, stale records, missing links, and audit-readiness gaps in one view.

Traceability Intelligence Orphan records, weak rationale, stale relationships, and uncovered hazards.

Review Workflow Phase gates, reviewer disposition, approval context, and change history.

AI Review Assistance Suggestion-only analysis for gaps, rationale, coverage, and review summaries.

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

Who It's For

Built for medical device teams doing real design-control work.

Dezi-Q is for teams that need clearer traceability, faster review preparation, and better audit readiness before records move into the final controlled system.

Medical device startups
Design-control consultants
RA/QA teams
Design and engineering teams
Teams preparing for design review
Teams preparing for audit

Buyer Pain

Design-control gaps are hard to see until they become audit problems.

Medical device teams often discover traceability and evidence problems late, when design reviews, audits, or submission preparation are already under pressure.

Orphan requirements
Stale risk links
Missing verification evidence
Weak rationale
Unlinked hazards and mitigations
Audit-readiness gaps
Change-impact confusion
Traceability tables that are difficult to maintain

Before and After

A project-scoped workspace for clearer execution

Before Dezi-Q

Teams manage requirements, hazards, risks, verification evidence, and design reviews across scattered documents and spreadsheets.

After Dezi-Q

Teams get a project-scoped workspace that surfaces missing links, stale records, weak rationale, and traceability gaps before they become audit findings.

Features

Design control software for traceable project execution

Clean up records, identify gaps, prepare review-ready baselines, and improve design-control execution while keeping humans in control.

Controlled Draft Import Import draft requirements, hazards, risks, and design-control content into a structured workspace.

Linked Design-Control Records Connect requirements, hazards, mitigations, verification evidence, and review status in one project view.

Traceability Gap Detection Surface missing links, orphan records, stale relationships, and weak coverage.

Audit Readiness

Move from draft records to review-ready baselines

Change Impact Visibility Understand what downstream records may be affected when a requirement, hazard, or design decision changes.

Review-Ready Baseline Package Generate a structured starting package for human review, including device description, intended use, indications, preliminary hazards, architecture notes, traceability starter, regulatory pathway guess, and key risk themes.

Audit Readiness Signals Highlight records that may need review before design reviews, audits, or submission preparation.

Trust and Compliance

AI assistance without losing control.

Dezi-Q is built for medical device teams that need explainability, review control, and audit-ready documentation. AI suggestions are review-first and do not silently approve, finalize, or change controlled records.

Human review required
Suggestion-only AI assistance
Explainable recommendations
Locked audit trail concept
Project-scoped context
Designed around medical device quality workflows
Aligned with ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR 820 expectations

Built by medical device quality and design-control professionals.

About

About Dezi-Q

Dezi-Q is an AI-assisted medical device development workspace for teams that need audit-ready design controls, medical device traceability, and structured review evidence without replacing the rest of their quality system.

Use it to organize active design-control work, review gaps, create controlled exports, and hand final records off to your existing repository or eQMS.

It is designed to make day-to-day design-control work easier to manage while supporting teams working toward expectations in ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR 820.