US
San Francisco Bay Area
46540 Fremont Blvd. Ste 514, Fremont, CA 94538, United States
+1-510-490-7899About VitalSigns
Building the Future
of Healthcare, Together.
We started as a medical device company. Today, we deliver the full platform — hardware, software, and the clinical pipeline that connects them.
Proactive Care
Early Warning
Real-Time Display
Our Journey
Innovation Timeline
2016
Company established with a vision to advance clinical-grade cardiac monitoring.
2016
2019
NMPA certification achieved — first major regulatory milestone in Mainland China.
2019
2022
TFDA certification achieved, expanding into Taiwan and regional markets.
2022
2025
FDA 510(k) clearance and ISO 13485 certification; new headquarters in Hsinchu.
2025
2026
Pursuing FDA SaMD approval and expanding clearance across Southeast Asia, South America, and the Middle East.
2026
Regulatory & Quality
The credentials behind the timeline.
VitalSigns operates under a certified quality management system and has achieved regulatory clearance in both the United States and Taiwan. Our engineering and manufacturing process follows the rigorous standards required for medical-grade devices deployed in clinical environments.
U.S. Cleared
FDA 510(k)
K243003
Cleared for clinical deployment in the United States.
Taiwan
TFDA Approved
Quality System
ISO 13485
Where We Are
Where to reach us.
Two locations. One mission: advancing medical technology for better patient outcomes.
HQ
Hsinchu, Taiwan
Taiyuen Hi-Tech Industrial Park, 6F-1, No. 12, Taiyuan 2nd Street, Zhubei City, Hsinchu County, 302042, Taiwan (R.O.C.)
+886-3-668-2091Build with us.
Whether you’re a hospital evaluating cardiac monitoring, a Hospital at Home operator, or a research team looking for a reliable ECG platform — we’d like to hear from you.