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This is the standard for a Quality Management System (“QMS”) for the design and manufacture of medical devices. Certification to the standard requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit, in which it must demonstrate its ability to consistently provide medical devices and related services that meet customer and applicable regulatory requirements.
This is the standard for a Quality Management System focused on customer satisfaction and continuous improvement. Certification to the standard means that we have demonstrated our ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, in addition to enhancing customer satisfaction through the effective application and improvement of the system to conform to such requirements.
