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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.
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 Annex SL is a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written. The aim of Annex SL is to enhance the consistency and alignment of MSS by providing a unifying and agreed-upon high level structure, identical core text and common terms and core definitions.
ISO 13482:2014 Robots and robotic devices – Safety requirements for personal care robots; 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
ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.
China’s exports slowed in November and its imports declined, falling below forecasts and underscoring potential weakness in trade at a time when its leaders are striving to boost the economy ...
Gold Glove first baseman Christian Walker and the Houston Astros agreed Friday to a $60 million, three-year contract, a person familiar with the negotiations told The Associated Press. Houston ...
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
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