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
Location: Cambridge, Massachusetts
Product: AI-driven Connected Lifecycle Management platform for regulated medical software (FDA/EU/ISO compliance)
Founded: 2020–2021 (team activity); launched November 2021
Recent funding: Series A announced Dec 5, 2023; Series B announced Sep 4, 2025
Regulated medical software and life-science product development; compliance, documentation, traceability, and quality management.
2021
Healthtech / MedTech SaaS
Seed rounds in 2021–2022 reported.
$14 million
Series A announced Dec 5, 2023 with participation from MIT's E14 Fund and Ubiquity Ventures.
$39 million
Series B announced Sep 4, 2025 with participation from Lightspeed Venture Partners, E14 Fund, Ubiquity Ventures, and 53 Stations.
“Company has participation from venture investors including Lightspeed Venture Partners, MIT's E14 Fund, Ubiquity Ventures, Transformation Capital, and 53 Stations.”