What is ISO 13485 Certification?
ISO 13485 is a certification that sets forth the standard of medical devices. Safety and quality assurance is important, especially in the case of medical equipment. To that end, prove that your medical devices fall to the right standards with ISO 13485 certification.
The international standard EN ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture, distribute, and are involved in any life cycle activities of medical devices.
When it comes to medical devices, two things are necessary:
The quality of the medical device
The safety when you are using such devices
Therefore, the regulatory standards for such devices are especially stringent and must be followed through the entire life cycle of the medical device. This is not a matter of the eight qualities; many organizations must demonstrate that they can manage their medical equipment. This demonstration comes in the form of ISO 13485:2016 certifications.
ISO 13485
