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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 15223-1:2016 Part 1: General requirements; ISO 15223-2:2010 Part 2: Symbol development, selection and validation; ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure; ISO 15226:1999 Technical product documentation – Life cycle model and allocation of documents
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ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).
The International Electrotechnical Commission (IEC; French: Commission électrotechnique internationale) is an international standards organization that prepares and publishes international standards for all electrical, electronic and related technologies.
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.
This template should always be substituted (i.e., use ... This template provides a datestamp in ISO 8601 format, and must be substituted to work correctly.
ISO 9241 is a multi-part standard from the International Organization for Standardization (ISO) covering ergonomics of human-system interaction and related, human-centered design processes (see also human-computer interaction). It is managed by the ISO Technical Committee 159.
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