OctoQMS gives medical device teams a modern platform to manage documents, CAPAs, training, complaints, audits, and more — all in one place. With visual analytics, multi-tenant isolation, and a tamper-evident audit trail.
Twelve integrated modules covering the full scope of your quality management system.
Create, review, approve, and manage controlled documents with a rich text editor, full version history, and revision tracking.
Track corrective and preventive actions through a structured 6-step workflow — from investigation to effectiveness verification.
Assign training plans, track completion, verify competency, and view compliance across your organization.
Record nonconforming products, manage disposition decisions, and link to CAPAs for systemic issues.
Capture customer complaints, investigate, assess reportability (MDR/Vigilance), and track resolution.
Schedule audits, manage checklists, record findings with ISO clause references, and track corrective actions.
Maintain your approved supplier list, track certifications, conduct evaluations, and monitor quality.
Manage engineering change orders through multi-step approval workflows with impact assessment tracking.
Register equipment, schedule calibrations, record results, and get alerts when calibrations are due.
Conduct ISO 14971 risk analyses with severity/probability/detectability scoring and residual risk tracking.
Track products, production lots, and maintain the foundation for Device History Records (DHR).
Schedule reviews, record minutes, track action items, and monitor KPIs across your entire quality system.
Go beyond KPI cards. OctoQMS Analytics gives you interactive charts showing CAPA trends, NCR disposition patterns, training compliance rates, supplier health, and equipment calibration timelines — all updated in real time from your quality data.
Monthly quality events trend, CAPA status distribution, type split, priority breakdown, NCR disposition analysis, complaint reportability.
Document status overview, type distribution, training compliance rate over 12 months, training status breakdown.
Supplier status distribution, equipment calibration timeline, audit activity by type, monthly closure rate.
Your dashboard shows open CAPAs, NCRs, complaints, training compliance, supplier status, calibration alerts, and more — all updated in real time. The onboarding wizard guides you through setup step by step.
Manage SOPs, work instructions, forms, and policies with a built-in rich text editor, version control, review workflows, and automatic review scheduling. Start from 10 included ISO 13485 templates or create from scratch. Every change is tracked in a tamper-evident audit trail.
Don't start from scratch. OctoQMS includes 10 ready-to-use document templates covering all key ISO 13485 processes — CAPA, complaints, audits, training, supplier qualification, and more. Click ‘Use Template’ and start editing immediately.
Guide every CAPA through a defined workflow — Open, Investigation, Planning, Implementation, Verification, Closed. Track root cause analysis, action items, and effectiveness checks.
Define training plans, link them to documents, track completion across your team, and verify competency. When a document changes, you'll know exactly who needs retraining.
Track supplier certifications, conduct periodic evaluations, and maintain a clear picture of your supply chain quality.
OctoQMS guides new organizations through a 12-step compliance roadmap — from setting up departments and inviting colleagues to creating your first document and scheduling your first audit. Track your progress and never wonder what to do next.
Define custom roles with module-level permissions. Manage users, departments, and system settings from a clean admin interface.
Track updates to ISO 13485, ISO 14971, 21 CFR 820, EU MDR, and other key standards. Never miss a regulatory change that affects your quality system.
| ISO Clause | Requirement | OctoQMS Module |
|---|---|---|
| 4.2 | Documentation Requirements | Document Control |
| 5.6 | Management Review | Management Review |
| 6.2 | Human Resources / Competence | Training Management |
| 7.4 | Purchasing | Supplier Management |
| 7.5 | Production and Service Provision | Products & Production Lots |
| 7.6 | Control of Monitoring Equipment | Equipment & Calibration |
| 8.2.2 | Internal Audit | Audit Management |
| 8.2.2 | Customer Feedback | Complaint Handling |
| 8.3 | Control of Nonconforming Product | NCR Management |
| 8.5 | Corrective and Preventive Action | CAPA Management |
| ISO 14971 | Risk Management | Risk Management |
| 21 CFR 820 | Quality System Regulation (FDA) | All Modules |
| 21 CFR Part 11 | Electronic Records & Signatures (FDA) | Document Control |
Purpose-built for medical device quality teams who need more than spreadsheets and legacy tools.
Every change across every module is recorded with chained SHA-256 checksums, providing cryptographic proof of data integrity for FDA auditors.
14 interactive charts across 3 tabs give you real insight into quality trends, training compliance, supplier health, and closure rates — not just static numbers.
12 integrated modules covering the full ISO 13485 scope plus analytics, templates, onboarding, global search, and CSV export. No juggling separate tools.
Each organization gets completely isolated data with tenant-scoped access control. Super admin dashboard for platform management.
Many QMS platforms cover 4–5 areas. OctoQMS covers all 12 — in one platform, one price.
| Module | OctoQMS | Typical eQMS | Spreadsheets |
|---|---|---|---|
| Document Control | ✓ | ✓ | ✕ |
| CAPA Management | ✓ | ✓ | ✕ |
| Training Management | ✓ | ✓ | ✕ |
| Risk Management (ISO 14971) | ✓ | ✓ | ✕ |
| NCR Management | ✓ | ✕ | ✕ |
| Complaint Handling | ✓ | ✕ | ✕ |
| Audit Management | ✓ | ✕ | ✕ |
| Supplier Management | ✓ | ✕ | ✕ |
| Change Control | ✓ | ✕ | ✕ |
| Equipment & Calibration | ✓ | ✕ | ✕ |
| Product Records / DHR | ✓ | ✕ | ✕ |
| Management Review | ✓ | ✕ | ✕ |
No hidden fees. Every plan includes all 12 modules.
No long-term contracts. No per-user fees. Cancel anytime.
Need implementation help? Ask about our consulting & onboarding services.
Choose the path that works for you.