Founded in 2002, Global Instrumentation is a medical-device company known for helping move Holter monitoring from analog tape to digital technology, including early internet connectivity. Based in East Syracuse, the company works with clinical researchers and medical technology partners, developing ECG monitoring systems and supporting them through regulatory approval and production. Global Instrumentation is ISO 13485 certified and FDA registered.
ISO 13485:2016
U.S. FDA Registered Manufacturer
Registration
MDSAP Medical Device Single Audit Program QMS Certification
EU MDR CE Certification for Global Matrix Holter System and Recorders
CE Certification for M5 Wearable ECG Recorder
FDA 510(k) Clearance for M5 Recorder
FDA
Quality certification
CEMARKING
Quality certification
CE
Quality certification