Quality
Quality Overview
Facilities/ISO Certification
 

IDEX Medical has multiple ISO certified facilities, with locations in the United States and in Asia. Our device component manufacturing and assembly is performed across these facilities, including locations in Oak Harbor, Washington; Bristol, Connecticut; Pocasset, Massachusetts; and Suzhou, P.R. China.  The following integrated capabilities and resources are shared among our global facilities:

    160,000 + square feet of facilities
    Over 450 skilled employees
    More than 40 experienced engineers
    Class 1000, 10,000, and 100,000 clean room facilities
    ISO 13485 and 9001 certified facilities


ISO 13485

IDEX Medical achieved ISO 13485 certification in 2003.  ISO 13485 is the international standard developed for medical device and component manufacturers. To be certified to this standard, companies must complete a rigorous auditing process to prove that systems meet ISO principles such as customer focus, process traceability, and dedication to continuous improvement. Several of our facilities are ISO 9001:2001 certified. 

Click here to see our ISO 13485 certificates