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The certification reduces regulatory risk during medical device manufacturing.
July 9, 2020
By: Sanmina Corporation
Sanmina Corporation, an integrated manufacturing solutions company that manufactures some of the world’s most complex and innovative electronic, optical and mechanical products, has achieved Medical Device Single Audit Program (MDSAP) certification at its facilities in Malaysia, Singapore and Sweden. The MDSAP certification enables the three manufacturing sites to be audited once by an accredited third party to satisfy regulations for medical device markets across Australia, Brazil, Canada, Japan and the United States. The certification ensures that consistent quality practices and audits are performed across regions, reducing regulatory risk for Sanmina’s medical device customers. “Medical devices have become increasingly sophisticated and our customers expect us to provide the highest levels of quality and consistency during the production of these complex products,” said Anca Thompson, senior vice president and chief quality officer at Sanmina. “Achieving MDSAP certification further validates to our customers that we are producing safe and effective medical products that comply with all of the regulatory requirements across these regions.” Collaborating with leading medical device and healthcare companies, Sanmina designs and manufactures a broad range of blood and molecular diagnostics, medical imaging and patient monitoring equipment, along with high-volume class I, II and III medical devices. Sanmina’s MDSAP certification follows its Thailand facility expansion, announced In early March. Augmenting its existing mission critical products, the site now has advanced custom packaging and assembly capabilities to manufacture advanced optical, high speed and radio frequency (RF) microelectronic assemblies and products. This expansion supports rapid growth for new technology products across the networking, 5G, data center, automotive/LIDAR and aerospace and defense markets. “A key priority at Sanmina is to leverage our vertical integration capabilities to help customers deliver innovative solutions that utilize the most advanced manufacturing methods and technologies,” said Jeff Reece, executive vice president of Business Development, Communications Networks at Sanmina. “Extending our optical and RF microelectronics expertise to Thailand enables us to develop new products and quickly ramp to volume production for customers across a variety of markets.” Key differentiators at Sanmina’s Thailand facility include:
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