Your own deployment under a custom agreement, operated under our QMS (ISO 13485 certified) and ISMS (ISO 27001 certified).
On Standard, you run it under your own quality system. On Enterprise Basic and Enterprise Advanced, we carry the regulatory work.
Every tier, from Lab to Enterprise Advanced, runs on the same platform and the same code base.
Who carries the regulatory work
Under your own quality system
With Kubyk carrying the regulatory work
Compare
| Kubyk Commercial | Standard | Enterprise Basic | Enterprise Advanced |
|---|---|---|---|
| Best for | A company with its own quality function that brings the platform into its own submissions, with commercial use permitted. | Multi-site feasibility, pivotal and investigator-initiated studies, the data and system side of a regulatory submission, and commercial deployments with no clinical data. | Cleared or approved devices with live patient data: post-market and post-approval studies including Section 522 surveillance, registries and real-world evidence, new-indication studies, complex pivotals at operational scale, and commercial operations. |
| Single sign-on | For your own organization and at tenant level, so each of your tenants signs its users in through its own identity provider | For your own organization | For your own organization and at tenant level, so each of your tenants signs its users in through its own identity provider |
| Devices in the field | Fleet management | Fleet management and secure over-the-air updates | Fleet management and secure over-the-air updates |
| Threshold alerts | Yes | Yes | Yes |
| Audit log | Yes | Yes | Yes |
| AI SaMD algorithm deployment | Deployment you control | Deployment you control | Deployment you control |
| Support | Dedicated support and SLA | Dedicated support and SLA | Dedicated support and SLA |
| Agreements | Master Services Agreement, template quality agreement, BAA, DPA where needed | Master Services Agreement, quality agreement, BAA, DPA where needed | Master Services Agreement, quality agreement, BAA, DPA where needed |
Three things place a program on Enterprise Advanced: a cleared device with live patient data, use of Advanced capabilities, or fleet scale.
Certificates and record
Every Kubyk Commercial deployment is operated under our QMS (ISO 13485 certified) and ISMS (ISO 27001 certified). Kubyk Lab, Lab+ and Scale are not operated under them. KeborMed Inc., the company that builds and runs Kubyk, holds the certificates and the FDA Master File.
| Certificate | Status | On |
|---|---|---|
| ISO 13485 | Recertified 2026, valid through 2029 | Standard, Enterprise Basic and Enterprise Advanced |
| ISO 27001 | Valid through 2027 | Standard, Enterprise Basic and Enterprise Advanced |
| FDA Master File | Active, referenced in multiple cleared 510(k) devices | Enterprise Basic and Enterprise Advanced |
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