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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 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 ...
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.
Download QR code; Print/export Download as PDF; Printable version; In other projects Wikimedia Commons; ... ISO 1 – ISO 1999; ISO 2000 – ISO 2999; ISO 3000 ...
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
ISO/IEC 30134-1:2016 Part 1: Overview and general requirements; ISO/IEC 30134-2:2016 Part 2: Power usage effectiveness (PUE) ISO/IEC 30134-3:2016 Part 3: Renewable energy factor (REF) ISO/IEC TS 30135 Information technology – Digital publishing – EPUB3. ISO/IEC TS 30135-1:2014 Part 1: EPUB3 Overview; ISO/IEC TS 30135-2:2014 Part 2: Publications
Military families protesting the Defense Department's anti-DEI push heckled Defense Secretary Pete Hegseth on his arrival at U.S. European Command headquarters in Germany on Tuesday. On a visit to ...
PDF is a standard for encoding documents in an "as printed" form that is portable between systems. However, the suitability of a PDF file for archival preservation depends on options chosen when the PDF is created: most notably, whether to embed the necessary fonts for rendering the document; whether to use encryption; and whether to preserve additional information from the original document ...
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