quality-systems

(4)
Company
Sware
Saas · Ai · Health

Sware

Sware is a Boston-based software company that modernizes GxP validation for life sciences. Its cloud-native Res_Q platform and developer-focused GxPNext product use AI and a decade of regulated validation knowledge to automate the computer system validation (CSV) work that the FDA and other regulators require - helping pharmaceutical, biotech, medical device and CDMO teams cut validation time and cost while staying audit-ready. Formerly Boston Technology Research (BTR), the company rebranded to Sware in 2022 and has raised roughly $26-27M to date.

gxp-validation · computer-system-validationRead →
Legend
Ellen Reilly
Executive · Operator · Advisor

Ellen Reilly

Ellen Reilly is the Chief Executive Officer and a board member of Sware, a Boston-based software company building Res_Q, an AI-powered GxP validation platform for the life sciences industry. With roughly four decades in life sciences quality and IT, Reilly has worked at Roche, advised clients at PwC, and led the launch of DocuSign's Part 11 product before taking the helm at Sware in 2023. She frames her work as tackling 'validation debt' - the accumulated, unpaid cost of testing and compliance that slows how quickly pharmaceutical and biotech companies can adopt new software.

ellen-reilly · swareRead →
Company
Inventive
Ai · Saas · Enterprise

Inventive

Inventive is a San Francisco startup building customer-facing AI that B2B SaaS companies embed inside their own products. Its first product, an embedded AI Analyst, lets a software vendor's customers use plain language to explore data, build custom reports, and act on insights. What sets Inventive apart is the layer around the agent: built-in quality and learning systems that test across accounts, catch mistakes, and propose fixes so the AI measurably improves week over week instead of degrading after a good demo. Founded in 2022 by ex-Google, Meta, and Microsoft product and platform veterans, the company launched out of stealth in June 2024 with a $6.5M seed round led by Wing VC.

embedded-ai · conversational-analyticsRead →
Company
COR Medical Ventures
Health · Hardware · Vc

COR Medical Ventures

COR Medical Ventures is a San Diego-area medical device development company that acts as the center of rotation for medtech innovation. Through three branches - consulting services, a venture studio, and distribution services - it partners with surgeon-inventors and corporations to take orthopedic, spine, and other devices from clinical idea to FDA clearance and market launch. Founded by engineer Ben Arnold, the firm has stood up a portfolio of more than a dozen independent companies spanning robotics, wearables, spinal fusion, and soft-tissue fixation.

medical-devices · venture-studioRead →