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Design controls. Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices ).
Medical device design in the United States. The United States medical device industry is one of the largest markets globally, exceeding $110 billion annually. In 2012 it represented 38% of the global market and more than 6500 medical device companies exist nationwide. These companies are primarily small-scale operations with fewer than 50 ...
ISO 13485. 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.
When designing medical devices, the tier of cybersecurity risk should be determined early in the process in order to establish a cybersecurity vulnerability and management approach (including a set of cybersecurity design controls). The medical device design approach employed should be consistent with the NIST Cybersecurity Framework for ...
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.
The US Food and Drug Administration requires that developers of medical device follow a system of design controls. A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of ...
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary standard [1] for the application of risk management to medical devices. [2] ". Voluntary standards do not replace national laws, with which standards' users are understood to comply and which take precedence" over voluntary standards [3] such as ISO ...
ISO 10993. The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1] For the purpose of the ISO 10993 family of ...
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