Design controls without a full eQMS rebuild

Built for medical device small to midsized companies, consultants, and product teams

Centralize medical device design controls in one workspace.

Build projects, manage traceability, control revisions, and export formal deliverables without replacing your existing QMS.

Dezi-Q is the structured authoring layer before final records move into your validated repository.

Project creation Templates and phased setup.

Traceability Requirements, risk, and FMEAs.

Controlled exports Draft, final, and shared revision baselines.

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 linkages, active editors, and release-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

Edited

REQ-1-004 updated 5 minutes ago. Linked hazard and specification references preserved.

Final

Specifications 1 exported as Rev B with changes since the previous final baseline.

Built for med device teams

Organize design controls without forcing a full QMS replacement project first.

Traceability-first

Link requirements, hazards, mitigations, FMEAs, and complaints in one controlled structure.

Export-first workflow

Prepare controlled Word and Excel outputs, then hand final records off to your existing repository.

Fit

What Dezi-Q is for

Dezi-Q is the authoring and revision layer used before final records are stored in the customer's existing QMS or document repository.

Medical device small to midsized companies.
Consultants building reusable project scaffolding.
Teams releasing signed PDFs or Word documents externally.

Workflow

How teams use it

Create a project from templates.
Build phased readiness and traceability.
Export draft, final, or reference copies.
Store released records in the external QMS.

Traceability

Core traceability features

Linked design-control records Connect requirements, specifications, hazards, mitigations, DFMEA, PFMEA, SFMEA, and complaints.

Document-instance support Split complex projects into scoped requirement or risk documents while preserving traceability.

Revision-aware exports Release draft, final, and reference copies with changes since the last final.

Collaboration

Controlled multi-user editing

Active editor visibility See who is editing traceability rows, readiness items, assessment sections, and exports.

Conflict prevention Row and section locks reduce silent overwrite risk during parallel work.

Shared revision baselines Final export history is shared across users for the same document instance.

About

About Dezi-Q

Dezi-Q is built for medical device teams that need structured design-control authoring 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.