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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 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/TS 13399-307:2016 Part 307: Creation and exchange of 3D models - End mills for indexable inserts; ISO/TS 13399-308:2016 Part 308: Creation and exchange of 3D models - Milling cutters with arbor hole for indexable inserts; ISO/TS 13399-309:2016 Part 309: Creation and exchange of 3D models - Tool holders for indexable inserts
The lawsuit filed in Los Angeles by fashion designer Bryana "Bana" Bongolan alleges the incident happened in 2016 while she was at the home of Mr Combs' then-girlfriend Casandra "Cassie" Ventura.
A woman has been fired after using company funds to throw a "farewell" party – despite never intending to leave the company. The woman's boss shares the story in a post published on Reddit ...
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