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
certification
U.S. FDA Registered Manufacturer
registration
MDSAP Medical Device Single Audit Program QMS Certification
certification
EU MDR CE Certification for Global Matrix Holter System and Recorders
certification
CE Certification for M5 Wearable ECG Recorder
certification
FDA 510(k) Clearance for M5 Recorder
certification