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  • alanbasker007 posted an update 3 months, 3 weeks ago

    ISO 13485 is a specifically developed standard for quality management systems of medical devices and equipment. This international standard specifies requirements to ensure continual improvement in the quality of medical devices. It is applicable to all sizes of the organization that manufactures medical equipment. Also, the specifications of ISO 13485 apply equally to the companies that deliver associated services.

    ISO 13485:2016 Certification