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Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11

Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11
Founded: 2021
Headquarters: Boston and Vienna
Employees: 97
Core product: AI-driven platform for automated documentation, traceability, and compliance for regulated software
Notable investors: Lightspeed Venture Partners, Transformation Capital, E14 Fund, Ubiquity Ventures, 53 Stations
Regulated software development and compliance for medical device, life-sciences, and other safety-critical industries.
2021
Regulatory compliance software / MedTech software
$14M
Announced December 5, 2023
$39M
Reported later growth round; date not stated in provided evidence
“Lightspeed Venture Partners, Transformation Capital, E14 Fund (MIT), Ubiquity Ventures, 53 Stations”
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