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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.
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.
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 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 ...
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 ...
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 standards are thought to represent the best interests and needs of the broader global society. [8] ISO 9001 is a set of standards for quality management systems. [9] ISO 13485 is a set of standards, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. [10]
This uses an international standard, ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes. World Bank Group explain that private standards cannot be used in technical regulation and have to be moved into the public standardization system before they can be used as the basis for technical regulations ...