iso-13485
(6)
Respiree
Respiree is a Singapore-founded digital health company (an A*STAR spin-off) building clinically validated AI that pairs FDA-cleared cardio-respiratory wearable sensors with software to track lung and heart biomarkers over time. Its 1Bio platform helps hospitals, health systems and biopharma detect patient deterioration - such as COPD flare-ups and heart failure - days in advance, powering remote patient monitoring, clinical decision support and decentralized clinical trials across Asia-Pacific, Australia and the United States.
RegDesk
RegDesk is an AI-powered regulatory information management platform for medical device, IVD, and pharma companies. It gives regulatory teams 24/7 access to up-to-date requirements across 120+ markets, automates submission-ready applications (GSPR checklists, Essential Principles, Declaration of Conformity), tracks changing regulations with daily alerts, and coordinates distributors - compressing submission work that once took three to six months into roughly a week.
Priya Paul
Priya Paul (Bhutani) is the founder and CEO of RegDesk, an AI-powered regulatory intelligence and management platform for medical device and pharmaceutical companies. A biomedical engineer turned regulatory strategist, she spent years watching life-changing devices stall in regulatory limbo - up to 80% of applications get rejected for reasons unrelated to safety - and built RegDesk in 2014 to compress submissions that once took months into days. She leads the company's product vision and global growth, and RegDesk is a certified Minority Business Enterprise.
Nventric, Inc.
Nventric, Inc. is a medical device company and contract development and manufacturing organization (CDMO) headquartered in Arcadia, California, with operations in Seoul, South Korea. Founded in 2019 by engineers with backgrounds at Abbott Vascular and Johnson & Johnson, Nventric designs and builds minimally invasive vascular devices - covering neurovascular, coronary, and electrophysiology applications - from concept through scalable, ISO 13485-certified manufacturing. Its own-branded neurovascular line, including the ULTRIVA stent retriever and EVOGLIDE distal access catheter, targets acute ischemic stroke, while its OEM/CDMO services help device companies move products from prototype to commercialization.
QbDVision
QbDVision is an Austin-based software company building the first cloud platform for Digital CMC (Chemistry, Manufacturing, and Controls), giving pharmaceutical and biotech teams a structured, single source of truth for product and process knowledge. By operationalizing Quality by Design principles, the platform replaces scattered documents and spreadsheets with connected, machine-readable data that accelerates drug development, tech transfer, and regulatory submissions. Founded in 2015 as CherryCircle Software, QbDVision now serves several of the world's largest biopharma organizations and CDMOs.
Sungwoo Min
Sungwoo Min is the founder and CEO of Nventric, Inc., an Arcadia, California medical device company that designs, develops, and contract-manufactures vascular devices for the neurovascular, electrophysiology, and coronary markets. A Stanford-trained mechanical engineer who cut his teeth on R&D and marketing at Abbott Vascular and later led R&D programs at Johnson & Johnson, he started Nventric in 2019 to build the kind of life-saving catheters, stents, and thrombectomy systems he used to ship at the giants - this time end to end, ISO 13485 certified, with operations in the US and South Korea. He is a named inventor on multiple US patents for mechanical thrombectomy devices.