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ISO 13485:2016 is the worldwide standard that frames the necessities for a Quality Administration Framework (QMS) for clinical gadgets. The quality management system (QMS) ensures that medical devices are produced, tested, and distributed in a manner that satisfies regulatory requirements and is safe and effective for their intended application. Design and development, production and service control, risk management, and documentation and records are all covered by the standard. Overall, ISO 13485:2016 provides a framework for medical device manufacturers to establish and maintain a quality management system (QMS) that satisfies regulatory requirements and guarantees medical device safety and effectiveness
The most recent version of the ISO 13485 standard, which was first published in 1996, is ISO 13485:2016. In order to keep up with changes in the medical device industry and regulatory requirements, the standard has undergone several revisions. Since its publication in March 2016, ISO 13485:2016 has undergone revisions to bring it into line with other quality management system standards and take into account shifts in the regulatory environment. ISO 13485:2016 is now widely acknowledged as the international standard for quality management systems for medical devices
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