Logistics

Spectrum Assembly Inc’s (SAI) Quality Management System is certified to ISO 13485, ISO 9001:2015 and AS 9100D. SAI ensures quality throughout the full product life cycle. Our Quality Management System identifies process standards that are documented and controlled to ensure consistent results. We control those process standards through Standard Operating Procedures (SOP), or Work Instructions(WI). SAI’s key performance indicators are constantly maintained, recorded and discussed to ensure compliance with best practices.

MEDICAL DEVICES ASSEMBLY

SAI assembles complex medical, commercial, industrial, and aerospace devices and fulfills customer orders directly from our customers sales system. SAI utilizes our PCBA department and Wire/Cable Harness department to build up sub-assemblies that feed into System Integration. Custom fabricated items are ordered through our vast supply chain. Devices are assembled, software and/or firmware is uploaded, and units subjected to rigorous quality control checks and data recording stations based on the Device History Record (DHR). Devices are then packed and shipped with care, either directly to our client’s end-users (such as hospitals, clinics, or laboratories), or directly to the end-user patients. SAI can also ship to distribution centers in bulk. If a unit needs to be repaired or returned, SAI is a one-stop-shop to return devices to their original specifications or upgraded versions that meet current market demand.