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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.
Design History File (DHF) 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 published version 2.0 of PDF, ISO 32000-2 in 2017, available for purchase, replacing the free specification provided by Adobe. [14] In December 2020, the second edition of PDF 2.0, ISO 32000-2:2020, was published, with clarifications, corrections, and critical updates to normative references [ 15 ] (ISO 32000-2 does not include any ...
ISO 13472-2:2010 Part 2: Spot method for reflective surfaces; ISO 13473 Characterization of pavement texture by use of surface profiles ISO 13473-1:1997 Part 1: Determination of Mean Profile Depth; ISO 13473-2:2002 Part 2: Terminology and basic requirements related to pavement texture profile analysis
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.
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