ISO has developed a specific standard ISO 13485 for improving the quality of medical devices and equipment. It provides requirements to ensure consistency in the quality of medical devices and equipment. It also helps improve the Quality Management System performance of the organizations. This international standard not only monitors and improves the quality of medical equipment but also ensures continual improvement in the associated services provided by the organizations. The ISO 13485 has a similar connection with ISO 9001 standard, but it also includes specific requirements to maintain and implement the performance of medical devices. So, it is easy to implement at any organization that produces and delivers medical devices and related services. Visit ISO 13485 Certification
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