Ads
related to: iso 13485:2016 pdf free download windows 10webstore.ansi.org has been visited by 100K+ users in the past month
Search results
Results from the WOW.Com Content Network
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.
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
ModusLink Receives ISO 13485 Certification for Medical Device Manufacturers —Leading manufacturers of consumer-oriented medical devices certify ModusLink according to their ISO-based quality ...
ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 ...
ISO 14289-1:2014 Part 1: Use of ISO 32000-1 (PDF/UA-1) ISO/TR 14292:2012 Health informatics – Personal health records – Definition, scope and context; ISO 14296:2016 Intelligent transport systems – Extension of map database specifications for applications of cooperative ITS
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
ISO 19444-1:2016 Part 1: Use of ISO 32000-2 (XFDF 3.0) ISO 19445:2016 Graphic technology - Metadata for graphic arts workflow - XMP metadata for image and document proofing ISO/IEC TR 19446:2015 Differences between the driving licences based on the ISO/IEC 18013 series and the European Union specifications
Ads
related to: iso 13485:2016 pdf free download windows 10webstore.ansi.org has been visited by 100K+ users in the past month