Admin
Configures access and the quality workspace.
Can
- Manage Users, People, controlled documents
- View Inspections, audit findings, corrective actions
- Medical Devices QMS
- Roles and permissions
Who can do what in Medical Devices QMS
Assign inspection, review, action, document and audit responsibilities to the right people.
How permissions work
Separate preparation from decision
Inspector submits inspection evidence; Quality Reviewer decides its disposition.
Give follow-up an owner
Corrective Action Owner records the cause and response, while Quality Reviewer handles effectiveness review.
Keep supporting records accountable
Document Controller maintains revisions and acknowledgments; Auditor owns audit work and findings.
Who can do what
| Role | Inspections | Nonconformances and corrective actions | Device history reviews | Supplier certificates | Documents and training | Audits |
|---|---|---|---|---|---|---|
| Admin | Edit | Edit | — | — | Edit | Edit |
| Inspector | Edit | Edit | Edit | Edit | View | View |
| Quality Reviewer | Approve | Approve | View | View | — | — |
| Corrective Action Owner | View | Edit | View | View | — | — |
| Document Controller | View | View | — | — | Edit | View |
| Auditor | — | View | — | — | View | Edit |
Each role in detail
Inspector
Performs assigned inspections and submits their evidence.
Can
- Manage Inspections, inspection checks, device history reviews, supplier certificates
- View controlled documents, People
Starts on: Pending device history reviews
Quality Reviewer
Decides inspection disposition and checks corrective action effectiveness.
Can
- Manage Nonconformances
- View inspection checks, device history reviews, supplier certificates
Reviews and approves
- Approve Inspections, corrective actions
Starts on: Device history review queue
Corrective Action Owner
Investigates failed scope and carries out the assigned action.
Can
- Manage corrective actions
- View Nonconformances, Inspections, inspection checks
Starts on: Open nonconformances
Document Controller
Maintains controlled revisions and follows acknowledgments.
Can
- Manage controlled documents, training acknowledgments
- View People
Starts on: Documents in review
Auditor
Plans audits and records findings against requirements.
Can
- Manage Audits, audit findings
- View controlled documents, corrective actions
Starts on: Audit work
Set up Medical Devices QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.