# AssurX

configurable enterprise quality and regulatory-compliance software for pharmaceutical, biotech and medical-device organizations, including FDA QMSR-transition and ISO 13485-aligned inspection-readiness support.


Source: https://en.bioecon.ru/companies/assurx/
Updated: 2026-08-18

- Country: United States

## Verifiable facts

| Fact | Value | Source |
| --- | --- | --- |
| Funding | None (privately held, bootstrapped) | https://checkthat.ai/brands/assurx, https://www.pharmaspotter.com/vendors/assurx |
| Capacity | Not publicly disclosed [medium confidence] | https://www.visionresearchreports.com/medical-device-complaint-management-market/37283 |
| Certification | ISO 27001:2022, SOC 2 Type 2 compliant | https://cruxi.ai/regulatory-providers/assurx, https://www.assurx.com/assurx/, https://www.pharmaspotter.com/vendors/assurx |
| Regulatory approval | HIPAA, GDPR, FDA (21 CFR Part 11, Part 820) compliant; support for ISO 13485, ISO 9001 compliance | https://cruxi.ai/regulatory-providers/assurx, https://www.assurx.com/assurx/, https://www.pharmaspotter.com/vendors/assurx |
| Production site | Reno, Nevada and Morgan Hill, California (offices) [medium confidence] | https://www.visionresearchreports.com/medical-device-complaint-management-market/37283 |
| Headcount | 51 (as of September 2024) [medium confidence] | https://www.pharmaspotter.com/vendors/assurx |
| Revenue | Estimated $10M - $25M (annual) [medium confidence] | https://checkthat.ai/brands/assurx |

Independent sources: checkthat.ai, cruxi.ai, pharmaspotter.com, visionresearchreports.com

## Technologies

- [Quality management systems (QMS) for biologics](https://en.bioecon.ru/technology/qms-for-biologics/)