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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 Ministry of Science and Technology (MOST, Vietnamese: Bộ Khoa học và Công nghệ) is a government ministry in Vietnam responsible for state administration of science and technology activities; development of science and technology potentials; intellectual property; standards, metrology and quality control; atomic energy, radiation and nuclear safety.
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.
Vietnam Standards (TCVN, Vietnamese: Tiêu chuẩn Việt Nam, lit. '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 ...
Former Deputy Prime Minister Vu Duc Dam at the founding ceremony of University of Medicine and Pharmacy, November 18, 2020. [1]On May 20, 2010, Prof. PhD. Mai Trong Nhuan (Former Director of VNU-HN) signed Decision to establish the School of Medicine and Pharmacy - Vietnam National University - Hanoi.
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Le Quy Don Technical University (Vietnamese: Đại học Kỹ thuật Lê Quý Đôn), also known as Military Technical Academy (Học viện Kỹ thuật Quân sự), [1] was founded in 1966 and is one of the national key universities in Vietnam. Le Quy Don Technical University has developed into an open, multidisciplinary, research-oriented ...
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.