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#Iso 13485 labeling requirements iso
In addition to being a regulatory requirement, an ISO 13485-compliant QMS makes good business sense because it helps device manufacturers minimize variation. The guidelines for maintaining effective quality management processes outlined in ISO 13485 are all geared toward the safe design, manufacture and distribution of effective medical devices. Since different countries often have different standards, ISO 13485 is intended to provide a globally harmonized model of QMS requirements for international markets.
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It is focused on maintaining QMS effectiveness and meeting regulatory and customer requirements. ISO 13485 is the most common medical device QMS regulatory standard in the world. The aim of this article is to answer frequently asked questions about ISO 13485 manufacturing and the related regulatory requirements that apply to medical device companies’ use of QMS. The ISO 13485 international standard is the world’s most widely used means of measuring the effectiveness of a medical device manufacturer’s quality management system (QMS). But all medical devices have one thing in common: they benefit immensely from being designed and manufactured in alignment with ISO 13485. Others are as simple as a tongue depressor. Some medical devices are as complex as a remote, personalized heart failure sensor.