ISO 13485 specifies requirements for an organization’s quality management system to provide medical devices and equipment that consistently meet customer requirements. It also helps the organizations to satisfy the applicable regulatory requirements. It reduces the risks and continually improves the QMS performance. The requirements of this standard also apply equally to the associated services provided by the organization. Regardless of size, the ISO 13485 is applicable to any organization that wants to demonstrate its ability to provide medical devices and related services.
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