ISO 13485 is a QMS standard that comes from the internationally recognized and accepted ISO 9000 quality management standard series. If you’re looking to establish a device’s effectiveness, then this might be the system for you. The overall goal of the standard is to reduce the risk associated with medical devices and technologies. To accomplish this, ISO 13485:2016 outlines certain requirements that a company must meet.
https://www.iascertification.com/all-about-iso-13485/
https://www.iascertification.com/all-about-iso-13485/
ISO 13485 is a QMS standard that comes from the internationally recognized and accepted ISO 9000 quality management standard series. If you’re looking to establish a device’s effectiveness, then this might be the system for you. The overall goal of the standard is to reduce the risk associated with medical devices and technologies. To accomplish this, ISO 13485:2016 outlines certain requirements that a company must meet.
https://www.iascertification.com/all-about-iso-13485/
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