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Ketryx eQMS provides medical-device quality workflows and QMS enforcement across connected development tools.
Verified
| Controlled document revision history | Ketryx says its document control includes automated version control and a full audit trail. |
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| Controlled document approval workflow | Ketryx describes role-based approvals and automated document approval workflows. |
| Electronic signatures | Ketryx describes browser biometric authentication for approvals and signatures. |
| Training and competency records | Not documented |
| CAPA workflow | Ketryx describes CAPA workflows with root-cause analysis integration and progress tracking from initiation to closure. |
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| Audit management | Not documented |
| Vendor-stated manufacturing positioning | Not documented |
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| Mobile quality inspections | Not documented |
| Nonconformance workflow | Ketryx describes non-conformance management with workflows and root-cause analysis integration. |
| Supplier quality | Not documented |
| Medical-device standards focus | Ketryx names ISO 13485, ISO 14971, EU MDR, IVDR, 21 CFR Part 11 and 21 CFR Part 820. |
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| 21 CFR Part 11 support statement | Ketryx states that its approvals and signatures are designed to meet 21 CFR Part 11 requirements. |
| Vendor-stated target company size | Ketryx describes its Free plan for pre-market companies with less than $2 million raised and its Startup plan for growing companies under 200 people. |
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| Published QMS price | Ketryx publishes a Free plan at $0 per year. |
| Free plan | Ketryx lists a Free plan. |
| Free trial | Not documented |
Ketryx eQMS provides medical-device quality workflows and QMS enforcement across connected development tools.
Ketryx names ISO 13485, ISO 14971, EU MDR, IVDR, 21 CFR Part 11 and Part 820 in its regulated product scope. No starting price is listed in the reviewed pricing material.
