Achieving FDA registration at its Chennai manufacturing facilities is an important milestone that builds on Sanmina's leadership in global medical device and instrument manufacturing. Sanmina manufactures complex products for the world's leading medical OEM companies in over twenty medical manufacturing facilities worldwide and designs medical products in three design centers with ISO 13485 design registrations, including the design center in Chennai. The quality system and audit protocols that come with FDA registration ensure that stringent manufacturing controls and documentation are in place during production of finished medical products to guarantee safety, quality and regulatory control.
"For nearly a decade, Sanmina's Chennai facility has been collaborating with customers to produce innovative medical products," said Charlie Mason, SVP, Medical Market Segment at Sanmina. "Our medical customers can now leverage our extensive capabilities in India to design and deliver finished medical products."
In addition to the medical electronic assemblies and modules that Sanmina already makes, FDA registration authorizes the site to produce finished products such as imaging systems, blood glucose meters, patient monitors and many other complex medical instruments and devices. The FDA registration rounds out a comprehensive list of certifications Sanmina has received in India that include TL 9000, EN/AS 9100, TS 16949 and ISO 13485.
"Sanmina has been at the forefront of product design and manufacturing in India, establishing a proven track record across many industries in one of the fastest growing economies in the world," said Michael Landy, EVP and COO of Integrated Manufacturing Solutions (EMS), Asia and Europe at Sanmina. "The new FDA registration reflects our continued commitment to provide the most comprehensive range of services to OEM customers around the world."
Founded in 2008, the 100-acre campus in Chennai, India is one of the highest technology manufacturing facilities in the region, producing the most advanced medical, communications, industrial, automotive and computing products in the world. Sanmina also operates its India Design Center (IDC) in Chennai. With an ISO 13485 design registration, the IDC is able to design finished medical products and offers a complete range of services, including DFx and test development solutions.