Showing posts with label quality assurance. Show all posts
Showing posts with label quality assurance. Show all posts

Friday, April 6, 2012

Design of Medical Electronic Devices Review

Design of Medical Electronic Devices
Average Reviews:

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In the modern age of publishing, there can be no excuses for sub-standard figures. Why is it then, that this book has technical illustrations that are both crude and clumsy? I was unable to find a single figure without at least one error.
The content was also extremely disappointing, being of a primarily superficial level. Ok for introduction to the topics, but no more. I was also a little disturbed with some of the referencing methods used by the author, where it appeared in one instance, that they essentially repeated portions of a referenced publication.
I strongly suggest spending your money elsewhere unless you are simply interested in learning about the basics.

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The design of medical electronics is unique because of the background needed by the engineers and scientists involved. Often the designer is a medical or life science professional without any training in electronics or design. Likewise, few engineers are specifically trained in biomedical engineering and have little or no exposure to the specific medical requirements of these devices. Design of Medical Electronic Devices presents all essential topics necessary for basic and advanced design. All aspects of the electronics of medical devices are also covered. This is an essential book for graduate students as well as professionals involved in the design of medical equipment. Covers every stage of the process, from design to manufacturing to implementation Topics covered include analogue/digital conversions, data acquisition, signal processing, optics, and reliability and failure

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Thursday, November 24, 2011

Six Sigma for Medical Device Design Review

Six Sigma for Medical Device Design
Average Reviews:

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The text is a reasonable summary of Six Sigma, DFSS and related tools as used in the medical device industry, but it is mostly a summary (only 100 pages). For $200+ I expected a lot more meat.

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For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do the same for the medical devices field.Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field. Authored by experienced professionals, it provides a how-to guide to implementing such a program while dispelling commonly held myths regarding deployment and adoption. This volume also links the philosophy with the FDA's Design Control regulation, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control.For management wishing to launch innovative medical devices as quickly as possible, this text establishes a way to align all levels of the organization to produce a high level of development that is both timely and compliant. It is also an excellent tool for technical and scientific personnel to understand the realities of business and markets and to optimize the product realization process.

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