ISO 13485:2016 specifies requirements for a quality management system where an organization needs to
demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Benefits of ISO 13485 : 2016
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Suitable for organizations in medical device related business
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To comply with medical devices sector customer requirements
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To comply with regulatory requirements of medical device sector
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Consistency in processes
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Improves product quality and controls in your process
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Prevents defect, reduces variation in the process and promotes improvement
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Improves traceability system
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Marketing tool to grow your business with medical device sector
