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Companies
that achieve ISO 13485:2003 certification for Medical Device Quality Management
must meet the stringent product quality requirements of the International
Organization of Standardization (ISO). ISO 13485:2003 certification involves
demonstrating best practices throughout all stages of a product’s
lifecycle: from prototype through manufacture.
ISO 13485:2003certification provides Birk customers real
savings in terms of cost and time to market. All of the pre-qualification
has already been done by ISO. This gives Birk the ability to hit the ground
running full-speed, and deliver fast turnaround on prototypes and production. |