QUALITY AND REGULATORY

When it comes to the intricate business of medical manufacturing, Sanmina sets the standard for quality and regulatory compliance. It’s a company-wide discipline, bolstered by “six sigma” programs and critical self-evaluation. We measure performance hourly, daily, weekly, monthly and quarterly, addressing salient issues that include product quality, on-time delivery and customer satisfaction. Twice yearly, Sanmina imposes rigorous multi-day audits on each facility, with best practices disseminated across all factories. FDA audits validate this concentrated effort; an inspector at a Sanmina facility overseas recently reported “no fault found” (NFF), a first in the auditor’s 20-year career of auditing international sites.

Medical customers gain further benefits from Sanmina’s quality and regulatory expertise: assistance in preparing 510k and Premarket Approval (PMA) submittals, as well as audit consultation on a project-by-project basis. Even if Sanmina hasn’t manufactured a particular medical device, we’ll support customers by orchestrating tests, pointing out improvements and leading the way through the complexities of global introduction. With the medical products industry evolving so rapidly, Sanmina proves to be the optimum partner for quality and regulatory compliance.

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