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Tag search results for: "certification iso 13485"
Introduction
ISO 13485 is an internationally recognized standard for
quality management systems (QMS) specific to the medical device industry.
Developed by the International Organization for Standardization (ISO), ISO
13485 provides a framework for medical device manufacturers to ensure
compliance with regulatory requirements, maintain product safety and efficacy,
and enhance customer satisfaction. This article delves into the significance of
ISO 13485, its key requirements, the process of certification, and the benefits
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