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    regina061
    Mar 24
      ·  Edited: Mar 24

    What are the Benefits of ISO 13485 Certification?

    in General Discussions
    • Promote coordination of regulatory requirements for medical device manufacturers on an international scale

    • Companies that are ISO 13485 certified enjoy the benefits of an increasing number of customers who have more reason to trust and buy consistently high quality products.

    • The management system according to ISO 13485 adopts a risk management approach which includes evaluation to identify & estimate risks, using risk controls and techniques with a view to eradicating hazardous situations throughout product realization.

    • Assuring clients that products comply with all relevant product & service oriented technical standards & regulations.

    • Emphasize cleanliness & sterility in the production area which in turn increases efficiency & improves safety in the workplace.

    • Improved access to more markets globally.


    sertifikasi ISO 13485

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