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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
ISO 9001 — Quality system standard ISO 13485 — Overarching standard for medical device manufacture Because of the high amounts of specificities, regulations, and challenges in the field of medical translation, some specialized translation companies have emerged who deal with medical translations exclusively.
The International Organization for Standardization (ISO / ˈ aɪ s oʊ /; [3] French: Organisation internationale de normalisation; Russian: Международная организация по стандартизации) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member ...
ISO 13485 specifies Quality Management System requirements for organizations involved in the design and manufacture of medical devices to demonstrate the ability to meet relevant regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and ...
Two new studies suggest once again the importance of getting a good night's sleep for good health over a lifetime, as scientists pursue new understandings of restorative deep sleep.
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