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    Noah aiden
    Jul 16

    What are the minimum requirements to achieve ISO 13485 Certification?

    in Education Forum

    The following are the minimum requirements for ISO 13485 Certificate:

    Medical devices must be manufactured in accordance with a compliant quality management system. The system’s documentation should meet the defined requirements of this standard.

    The manufacturer should have an efficient quality management system that is capable of meeting all their responsibilities under the Quality System Regulations (QSR) and other applicable regulations.

    iso 13485 certificate

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