Design Issues in Medical Devices

Medical device development is more complex than the development of conventional products due to a huge variety of regulations, standards, and controls have to be overcome, which often depends on the local regulations of each country. Medical devices have to pass through more phases of product file c...

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Bibliographic Details
Published inBiomedical Devices p. 1
Main Authors Ferrer, Inés, Grabalosa, Jordi, Elias‐Zuñiga, Alex, Rodriguez, Ciro Angel
Format Book Chapter
LanguageEnglish
Published United States John Wiley & Sons 2017
John Wiley & Sons, Incorporated
John Wiley & Sons, Inc
Subjects
Biochemistry, Biology & Biotechnology
BIOLOGY, LIFE SCIENCES
Biotechnology
case study
design control
design process
MECHANICAL ENGINEERING & MATERIALS
medical device development
product life circle
validation
verification
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Summary:Medical device development is more complex than the development of conventional products due to a huge variety of regulations, standards, and controls have to be overcome, which often depends on the local regulations of each country. Medical devices have to pass through more phases of product file cycle, such as preclinical and clinical testing, prototyping and final validation, because complete safety is to be guaranteed. This chapter reviews several design models adapted to develop medical devices and explain two case studies where this type of formal methods are being applied. These standardized models of product development processes ( PDP ) state the set of activities to be followed to ensure the success of the final design, reduce development time and the final product cost.
ISBN:9781118478929
1118478924
DOI:10.1002/9781119267034.ch2