ISO13485 Certification for Medical Device Manufacturing

April 23, 2013

Somewhat different, yet similar to ISO9000, compliance to this certification allows Astronic to provide many levels of manufacturing service for the medical device field, from design verification using HALT techniques, to Micro Assembly, Test and Verification, and Full Turn Key Manufacturing.

Astronic has completed the rigorous ISO13485 Certification for the manufacturing of Medical Devices, and in January of 2014 will enter its first manufacturing agreement for a Medical Device.

The ISO13485 Certification combined with Astronic’s 30 yrs + manufacturing experience, spacious facility, pro-active technology stance, provides assurance of both Quality Manufacturing and requisite Traceability and Documentation.