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.

Country: United States

Coverage

	US
digital-it	✓

Regulatorsfdaema

Verifiable facts

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

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

Technologies

Name	Cluster	Risk
Quality management systems (QMS) for biologics	digital-it	Low	→

Compiled by BIOECON from primary sources.

Compliance Bioecon is an information intermediary; it is not a regulator, a certification body, or a legal advisor. When working with public-sector customers (procurement under 44-FZ / 223-FZ), Bioecon acts solely as an independent analytical platform, with no remuneration from suppliers.