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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.
The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01. [34] [35] The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. ISO 13485:2016 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of ...
IEC 62304:2006 outlines the life cycle requirements for medical device software, establishing a framework for processes, activities, and tasks throughout the software's life cycle. Additionally, ISO 13485:2016 specifies requirements for a quality management system in the design and manufacture of medical devices, including software components.
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.
ISO/IEC 23005-2:2016 Part 2: Control information; ISO/IEC 23005-3:2016 Part 3: Sensory information; ISO/IEC 23005-4:2016 Part 4: Virtual world object characteristics; ISO/IEC 23005-5:2016 Part 5: Data formats for interaction devices; ISO/IEC 23005-6:2016 Part 6: Common types and tools; ISO/IEC 23005-7:2017 Part 7: Conformance and reference ...
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
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