# 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://cn.bioecon.ru/companies/assurx/
Updated: 2026-08-18

- 国家: United States

## 可核验事实

| 事实 | 数值 | 来源 |
| --- | --- | --- |
| 融资 | 无(私人持有,自筹资金) | https://checkthat.ai/brands/assurx, https://www.pharmaspotter.com/vendors/assurx |
| 产能 | 未公开披露 [中等置信度] | https://www.visionresearchreports.com/medical-device-complaint-management-market/37283 |
| 认证 | ISO 27001:2022,符合SOC 2 Type 2 | https://cruxi.ai/regulatory-providers/assurx, https://www.assurx.com/assurx/, https://www.pharmaspotter.com/vendors/assurx |
| 监管批准 | 符合 HIPAA、GDPR、FDA（21 CFR Part 11、Part 820）要求；支持符合 ISO 13485、ISO 9001 | https://cruxi.ai/regulatory-providers/assurx, https://www.assurx.com/assurx/, https://www.pharmaspotter.com/vendors/assurx |
| 生产基地 | 内华达州里诺及加利福尼亚州摩根山（办公室） [中等置信度] | https://www.visionresearchreports.com/medical-device-complaint-management-market/37283 |
| 员工人数 | 51（截至2024年9月） [中等置信度] | https://www.pharmaspotter.com/vendors/assurx |
| 营收 | 预计每年$10M–$25M [中等置信度] | https://checkthat.ai/brands/assurx |

独立来源: checkthat.ai, cruxi.ai, pharmaspotter.com, visionresearchreports.com

## 技术

- [生物制品质量管理系统（QMS）](https://cn.bioecon.ru/technology/qms-for-biologics/)