![]() What countries require ISO 13485 certification?.Who needs QMS certification under ISO 13485?.What is a Quality Management System (QMS)?.Read the introduction, definitions and requirements of EN ISO 13485:2016 below. Certification of a Quality Management System according to ISO 13485 In this article, we give an overview on the ISO 13485 standard, who needs it, what must be considered when certifying a QMS under it, and more.
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