QHSE and quality software for medical device manufacturing
Q-Hub helps medical device manufacturers run ISO 13485-aligned quality workflows, controlled documents, audits, non-conformances and training, with less manual admin.
Sound familiar?
ISO 13485 documents hard to keep controlled
Non-conformances and CAPAs tracked in spreadsheets
Training and competence records out of date
Audit prep taking days
One platform for every medical device manufacturing compliance workflow
Audit & inspection management
Schedule, conduct and close out audits and inspections on any device, online or offline.
Document control
Version control, approval workflows and access permissions with a full audit trail.
Incident & NCR management
Capture non-conformances and incidents, investigate root cause, and track corrective actions to closure.
Training & competence
Competency matrices, automated renewal reminders and training records across your team.
Built for medical device quality standards
ISO 13485
Medical device quality management
ISO 9001
Quality management
The numbers our customers see
Q-Hub vs paper and spreadsheets for medical device manufacturers
| Feature | Paper + spreadsheets | Q-Hub |
|---|---|---|
| ISO 13485 design control and DHF traceability | Manual | ✓ |
| ISO 14971 risk management file linked to controls | Partial | ✓ |
| Complaint handling and MDR vigilance workflow | Manual | ✓ |
| Closed-loop CAPA with effectiveness checks | ✗ | ✓ |
| UDI and device traceability records | Limited | ✓ |
| Notified-body audit trail and e-signatures | ✗ | ✓ |
| Calibration and equipment control alerts | Manual | ✓ |
Compliance ROI calculator
Based on 60% time reduction. Actual savings depend on current processes.
See Q-Hub for medical device manufacturers in action
Walk your ISO 13485 QMS, risk file and CAPA process through one audit-ready platform your notified body will trust.
Explore Q-Hub for medical device
The tools and standards behind medical device compliance.
Medical Device Manufacturing compliance FAQs
Yes. Document Hub gives you controlled procedures, version history and enforced approvals, while Audit Hub covers internal audits and findings. Together they map directly to ISO 13485 clauses, so your QMS documentation, records and evidence stay current and ready for notified-body and FDA inspection.
Register Hub holds your risk management file, capturing hazards, harms and risk controls for each device. You link controls back to design outputs and CAPA actions, so residual risk is traceable and your ISO 14971 file evolves alongside the product rather than sitting in a stale spreadsheet.
Yes. Document Hub structures design inputs, outputs, reviews and verification records with full traceability, forming a living design history file. Every change is versioned and approved, so you can demonstrate design control conformity under ISO 13485 without hunting through folders.
Smart Forms capture complaints from any device or team, then route them through triage, investigation and reportability assessment. CAPA links investigations to corrective action, and dashboards flag trends early, helping you meet EU MDR vigilance timelines and FDA adverse-event expectations with a defensible record.
Yes. CAPA connects nonconformances, complaints and audit findings to root-cause analysis, corrective actions, owners and due dates. Effectiveness checks are built in, so actions cannot close prematurely. You get the closed-loop discipline auditors expect and clear evidence that issues are genuinely resolved.
Q-Hub keeps documents, training records, calibration data and CAPA in one searchable system with time-stamped e-signatures and full audit trails. When your notified body arrives, you retrieve evidence in seconds rather than days, demonstrating a controlled, traceable QMS against ISO 13485 and MDR requirements.