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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.
The ISO 13485 standard is a derivative of the ISO 9001 standard. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to those devices and services.
Vua tiếng Việt (lit. ' King of Vietnamese ' ) is a Vietnamese television quiz show featuring Vietnamese vocabulary and language, produced by Vietnam Television . [ 1 ] [ 2 ] The programme is aired on 8:30 pm every Friday on VTV3, starting from 10 September 2021, with the main host Nguyễn Xuân Bắc.
From Wikipedia, the free encyclopedia. Redirect page
Vietnamese uses 22 letters of the ISO basic Latin alphabet.The 4 remaining letters aren't 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.
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.
Vingroup JSC (Vietnamese: Tập đoàn Vingroup – Công ty CP, lit. 'Vingroup Group – JSC') is a Vietnamese conglomerate headquartered in Long Bien district, Hanoi. Vingroup is one of the largest conglomerates of Vietnam, [3] focusing on technology, industry, [4] real estate