MedQdoc is a validated electronic quality management system for medical-device and MedTech companies.
MedQdoc lists ISO 13485:2016, ISO 14971:2019 and FDA 21 CFR Part 820. Published entry pricing: €410 per month.
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MedQdoc is a validated electronic quality management system for medical-device and MedTech companies.
Verified
| Controlled document revision history | MedQdoc lists document version control. |
|---|---|
| Controlled document approval workflow | MedQdoc lists document approval workflows. |
| Electronic signatures | MedQdoc describes electronic signature workflows. |
| Training and competency records | Not documented |
| CAPA workflow | Not documented |
|---|---|
| Audit management | Not documented |
| Medical-device standards focus | ISO 13485:2016; ISO 14971:2019; FDA 21 CFR Part 820 |
|---|---|
| 21 CFR Part 11 support statement | Designed to support Part 11; customer assessment and validation remain required |
| Vendor-stated target company size | Medical device and IVD companies of all sizes |
|---|---|
| Published QMS price | MedQdoc publishes Startup pricing based on a five-user minimum. |
| Free plan | Not documented |
| Free trial | Not documented |
MedQdoc is a validated electronic quality management system for medical-device and MedTech companies.
MedQdoc lists ISO 13485:2016, ISO 14971:2019 and FDA 21 CFR Part 820. Published entry pricing: €410 per month.