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  • Title: Update on ISO 13485.
    Author: Donawa M.
    Journal: Med Device Technol; 2002 Mar; 13(2):23-5. PubMed ID: 11984989.
    Abstract:
    A previous article discussed the impact that new quality management system standards are likely to have on the CE-marking process. The draft international standard for medical device quality systems has now been published. This article will discuss important issues related to the new standard.
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