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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.
Vietnamese uses 22 letters of the ISO basic Latin alphabet.The four remaining letters are not considered part of the Vietnamese alphabet although they are used to write loanwords, languages of other ethnic groups in the country based on Vietnamese phonetics to differentiate the meanings or even Vietnamese dialects, for example: dz or z for southerner pronunciation of v in standard Vietnamese.
ISO 13485:2016 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices. The standard is the basis for regulatory compliance in local markets, and most export markets.
The Vietnamese Wikipedia initially went online in November 2002, with a front page and an article about the Internet Society.The project received little attention and did not begin to receive significant contributions until it was "restarted" in October 2003 [3] and the newer, Unicode-capable MediaWiki software was installed soon after.
Vietnamese (tiếng Việt) is an Austroasiatic language spoken primarily in Vietnam where it is the official language. It belongs to the Vietic subgroup of the Austroasiatic language family. [6] Vietnamese is spoken natively by around 85 million people, [1] several times as many as the rest of the Austroasiatic family combined. [7]
'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 ...
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