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by Sandra Shefelbine,etc.,John Clarkson,Roy Farmer,Stephen Eason

eBook Good Design Practice for Medical Devices and Equipment: Requirements Capture download ISBN: 1902546105
Author: Sandra Shefelbine,etc.,John Clarkson,Roy Farmer,Stephen Eason
Publisher: Institute for Manufacturing (March 15, 2002)
Language: English
ePub: 1211 kb
Fb2: 1145 kb
Rating: 4.4
Other formats: azw docx mbr lrf
Category: Engineering
Subcategory: Engineering

She is now at Stanford University studying for a PhD. Dr John Clarkson is a University Reader in Engineering Design and Director of the Cambridge Engineering Design Centre. Roy Farmer is a Royal Academy of Engineering Visiting Professor.

Good design practice for medical devices and. Equipment requirements capture.

Stephen Eason is the author of Good Design Practice For Medical . See if your friends have read any of Stephen Eason's books.

See if your friends have read any of Stephen Eason's books. Stephen Eason’s Followers. None yet. Stephen Eason. Good Design Practice For Medical Devices And Equipment by. Sandra Shefelbine, John Clarkson.

9 OVERVIEW OF DESIGN AND REQUIREMENTS CAPTURE Design is the prolonged checking, pondering, and . 36 REGULATORY REQUIREMENTS All medical devices must be approved before they are released to market. Devices fall into certain type categories

9 OVERVIEW OF DESIGN AND REQUIREMENTS CAPTURE Design is the prolonged checking, pondering, and compromising on requirements which are often quite contradictory until there appears - as the end product of numerous associations of ideas, a network of ideas - the design. Devices fall into certain type categories. Broadly speaking, for each market area and for each type of device there are internationally and nationally agreed requirements with which the device must be designed to conform.

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Investigation of Storytelling as a Requirements Elicitation Method for Medical Devices. Kimberly Ann Gausepohl.

oceedings{, title {Good design practice for medical devices and equipment - requirements capture}, author {Sandra Shefelbine and Pj Clarkson and Richard Donald Trafford Farmer}, year {2002} . Investigation of Storytelling as a Requirements Elicitation Method for Medical Devices.

placed design controls on the design of medical devices and manufacturing equipment i. 5 Good practice in requirements capture

Interviews were also conducted by Shefelbine and Ottavi with device designers. to further refine the description of the problem and to ask them what methods or tools would. aid them in writing requirements specifications. 5 Good practice in requirements capture.

Good design practice for medical devices. In particular, Duncan Bishop, Stephen Eason and Stewart Fox contributed a significant amount of their time and gave much valuable advice as work progressed. CCL now make active use of the methodology developed.

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Find nearly any book by Sandra Shefelbine. Get the best deal by comparing prices from over 100,000 booksellers. by Sandra Shefelbine, John Clarkson, Roy Farmer, Stephen Eason. ISBN 9781902546100 (978-1-902546-10-0) Softcover, Institute for Manufacturing, 2002. Founded in 1997, BookFinder. com has become a leading book price comparison site

Medical devices and their associated process equipment must be reliable and fit for purpose. In light of the recent changes to the medical device regulations, manufacturers must now take an integrated approach to design, development and validation.

Medical devices and their associated process equipment must be reliable and fit for purpose. Good design practice encourages this integrated approach while ensuring fitness for purpose within commercial reality.

Due to the direct health and safety effects they have on users, medical devices are subject to many regulations and must undergo extensive validation procedures before they are allowed on the market. Requirements formulation is one of the most important aspects of the design process because it lays the foundation for the rest of the design. This workbook explains a method for capturing requirements. It does not provide information on how to gather information and perform background research. Rather, it details how to organise information that has already been gathered into a requirements specification. The method involves three phases: defining the problem and the business requirements; determining and detailing the functions required to satisfy the problem; and documenting the results in a requirements specification. Three tools are provided to facilitate the above process: functional analysis - for determining functional and performance characteristics; matric checklist - which covers a wide range of requirements including reliability, safety and documentation; and regulatory guidelines - information on regulations and standards. This workbook is intended to be used by medical device designers, engineer and project managers, and procurement officers. Pervious experience in writing specificaitons is not necessary, but experience in medical device design is likely to be helpful.