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    ISO 13485-2016 Certification

    ISO 13485:2016: Medical certification is a continual achievement

    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
    For More Information: (860) 739-4170    sales@birkmfg.com

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