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Tag: ISO 13485

ISO 13485: The Global Quality Management Systems Standard for Medical Devices

Posted on 28 March 2021 (17 April 2021) by tim
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With the explosion of medical devices and manufacturers, a need was realized to develop a medical-device-specific standard based on ISO 9001. The result is ISO 13485.

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Posted in medical device, regulationsTagged European Union, ISO 13485, medical devices, regulations
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