Austin, Texas based Electronic Contract Manufacturer Meets ISO Quality Standard for Medical Devices
January 7, 2019 Austin, TX - East/West Manufacturing Enterprises (East/West), an electronic contract manufacturer today announced that it has achieved ISO 13485:2016 certification, an internationally recognized quality standard specific to the medical device industry. East/West also renewed its ISO 9001:2015 certification, and is one of the only contract manufacturers in central Texas to have both quality management certifications.
The ISO 13485 standard has been created and influenced by the major medical device regulatory bodies across the world. ISO 13485:2016 is an international standard that defines common medical regulatory concepts to provide assurance that a company meets certain quality management system expectations. The 2016 version of the international standard is a major revision of the 2003 version, with an increased focus on risk management and risk-based decision-making processes at both the quality management system and product levels.
In addition to achieving ISO 13485:2016 and ISO 9001:2015 certifications, East/West experienced strong growth and improvements in 2018. Highlights include:
Record Q4 2018 revenue increase of 50% over the same period last year
Ten new customers during the year
SMT equipment purchases enabling a capacity increase of 2X
In-house Certified IPC Trainer and IPC-A-610 Certified Specialists to ensure compliance with IPC 610 Class II and III manufacturing
ITAR registration renewal for continued work on defense related technologies
“2018 has been another year of solid growth for East/West” said Andy Salo, President of East/West Manufacturing Enterprises. "We are working closely with our customers as their manufacturing arm to deliver high quality products, while achieving reduced customer costs through our process efficiency and strong distributor relationships.”