ISO 13485:2016


Companies that achieve ISO 13485:2016 certification for Medical Device Quality Management must meet the stringent product quality requirements of the International Organization of Standardization (ISO). ISO 13485:2016 certification involves demonstrating best practices throughout all stages of a product's lifecycle: from prototype through manufacture.

ISO 13485:2016 certification 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.

Benefits to you

Internationally recognized Focused on measured continual improvement Focused on competitive pricing Controlled documentation and record-keeping Decision-making based on data Focused on increased customer satisfaction

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