The standards for a Quality Management System for Medical Device Manufacturing are defined in the International Standard ISO 13485 consultant in Egypt, which ensures that all medical devices conform to legal requirements and consumer demands. The quality management standard ISO 9001, which is available to companies in a wide range of industries, is the origin of ISO 13485. However, some of the standards in ISO 9001 were difficult to apply to the medical device and pharmaceutical industries due to their unique requirements, so ISO 13485 was created to address these requirements.
