Sanmina, an integrated manufacturing solutions company, has achieved Medical Device Single Audit Program (MDSAP) certification at its facilities in Malaysia, Singapore and Sweden.
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, by collaborating with medical device and healthcare companies.
The MDSAP certification will enable the three manufacturing sites to be audited once by an accredited third party in order 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.
Anca Thompson, SVP and chief quality officer at Sanmina, commented: “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.
“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.”