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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.
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.
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 ...
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 ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.