ISO 13485 specifies requirements for the continual improvement of medical devices’ quality and performance. Also, it establishes that medical equipment is safe and reliable to use. SO 13485 is an internationally recognized standard for a quality management system, especially for medical devices and equipment. The requirements of the ISO 13485 apply to any organization, regardless of size, that develops and provides medical devices. This standard also applies equally to the associated services that the organization provides. ISO 13485 Certification
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