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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.
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.
The National Standardization Agency of Indonesia (Indonesian: Badan Standardisasi Nasional; BSN) is the International Organization for Standardization (ISO) member body for Indonesia. [1] BSN is a non-ministerial Indonesian government agency with the main task of carrying out governmental tasks in the field of standardization and conformity ...
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.
If you’re stuck on today’s Wordle answer, we’re here to help—but beware of spoilers for Wordle 1262 ahead. Let's start with a few hints.
Rapper Ye is facing allegations of choking a model in a "pornographic" way on the set of a 2010 music video, according to a new lawsuit.. Lawyers for model and former "America's Next Top Model ...
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
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