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ISO 13485 Certification
The ISO 13485 certification stands for quality management systems for medical devices. It is used to ensure the quality of design and manufacturing of medical devices and published on March 1st, 2016. The organizations involved in the design, production, installation and servicing of medical devices and related services are eligible for this certification. It is essential for organizations that deal with medical device or equipment manufacturing. Adhering to the ISO 13485 and process approach provides the opportunity to improve the manufacturing process by revealing the existing flaws.
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