Medical devices come in close contact with patients and range from minor support for medical conditions to lifesaving capability. As such, they demand high quality management criteria. Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. Registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMP), maintenance of documentation, and traceability of products. Certification to ISO 13485 offers a major competitive edge for medical device organizations.
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