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Sep 4, - Design Controls for Medical Devices: A Short Guide. Design Controls. The term design controls originates from FDA regulations, but it is as well mentioned in theISO Design and development planning. Design input. Design output. Design review. Design verification. Design validation. Design transfer.
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- Design Controls for the Medical Device Industry
- Design Controls for Medical Devices: An Introduction
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- Design Controls for Medical Devices: A Short Guide
Planning also enables management to have more control over the design and development process by communicating policies, procedures, and goals more clearly to the members of the development team. The physical structure and the performance requirement form the basis of a device design and this process is called design input. The starting point of a product design is Design Input.
Developing requirements is the most important factor of design input, which forms the design tasks that are to be followed for the validation of the design. This is the reason why development of the requirements is the single most important design control activity followed by design input. The result of each design phase and the total design effort at the end of product development is called design output.
The master record is formed on the basis of design output.
The final design output consists of device, packaging, and labeling and the master record of the device. Design output should be expressed in terms that allow satisfactory evaluation of conformance to design input requirements and should identify the characteristics of the design that are crucial to the safety and proper functioning of the device.
Design Controls for the Medical Device Industry
This raises some fundamental issues for developers:. This issue is important because voluminous records are produced from a typical development project, some of which may not be categorized as design output and design output must be reasonably comprehensive to be effective. An item may be considered as design output if it defines, describes, or elaborates an element of the design implementation.
Examples include flowcharts, block diagrams, software code, and system or subsystem design specifications. The design output in one stage can sometimes be a part of the design input of subsequent stages.
Design Controls for Medical Devices: An Introduction
Design review means a comprehensive, documented, and a systematic examination of the design. This will help in determining the adequacy of the design requirement and also in evaluating the capability of the design to meet these requirements and to identify problems. Many types of reviews occur during the course of developing a product. Reviews may have both an internal and external focus.
The internal focus is on the feasibility and produceability of the design with respect to support and manufacturing capabilities, whereas the external focus is whether the device design is viewed from the perspective of the user.
Validation is the process of making sure that user needs are met without any objective interference. The usual process to follow in order to validate a device could be inspections and analysis in some cases. However, the main goal of validation is to make sure that the device should provide the intended medical benefits in actual use condition.
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Validation is a cumulative effort to assure that the design will conform with user needs and intended use. Design verification is a process of making sure that specific requirements are met during the product development. It also includes a detailed examination of design aspects at various stages in the development.
Design controls, if implemented properly can reduce product defects and increase end-user satisfaction. There are two principal elements involved in design changes:. Design history file DHF means a compilation of records which describes the design history of a finished device. Design control regulation mandates DHF, which illustrates the relationship between all the Design Controls. Most VitalSource eBooks are available in a reflowable EPUB format which allows you to resize text to suit you and enables other accessibility features.
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