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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 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of a medical device to establish a technical file (medical device file, device master record, design dossier, or device master file). Annex II and III of the EU medical device regulation (MDR) and of the In-vitro Diagnostic Regulation (IVDR) contain an overview of the contents and ...
'Standards of Viet Nam'), or the Vietnamese National Standards (Vietnamese: Tiêu chuẩn Quốc gia Việt Nam, lit. 'National Standards of Vietnam'), are the national standards of Vietnam issued by the Vietnam Standard and Quality Institute, part of the Directorate for Standards, Metrology and Quality (STAMEQ). These standards are identified ...
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.
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ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes ISO/IEC 13490 Information technology – Volume and file structure of read-only and write-once compact disk media for information interchange
Following the increasing of Internet usage in Vietnam, many online encyclopedias were published. The two largest online Vietnamese-language encyclopedias are Từ điển bách khoa toàn thư Việt Nam, a state encyclopedia, and Vietnamese Wikipedia, a project of the Wikimedia Foundation.