Download Handbook of Medical Device Design by Richard C. Fries PDF

By Richard C. Fries

The guide of clinical gadget layout  offers a assessment of regulatory and criteria matters in scientific machine layout, together with FDA laws, kinds of 510 (k), the ISO 9000 sequence, and clinical gadget directives. It identifies how one can verify and rfile buyer wishes and gadget standards. It additionally establishes reliability and caliber metrics at some point of the product improvement cycle. issues comprise

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W a n , J. , "Regulationof Computer Hardware andSoftware as Medical Devices," Canadian Computer Law Reporter. Volume 6, Number 3, January, 1987. Magee, Stanand Leondard Tripp, Guide to &ftware Engineering Standards and Specijications. Boston, Massachusetts, Artech House, 1997. Magee, Stan, "ISO/IEC S o h a r e Life Cycle Standard 12207, Datapro Management of Applications &ftware. February, 1995. " I I i . . . . FDA Regulations 19 Munsey, Rodney R. and Howard M. Holstein, "FDNGMPMDR Inspections: Obligations and Rights," in The Medical Device Industry: Science, Technology, and Regulation in a Competitive Environment.

Rich, "The Animal Testing Issue," in The Medical Device Industry: Skience, Technoiom, and Reguiation in a Competitive Environment. , 19W. U. S. Congress, House Committeeon Interstate andForeign Commerce. Medical Devices. Hearings before the Subcommittee on Public Health andthe Environment. October 23-24,1973. S. Government PrintingOflice, 1973. Wholey, Mark H. and Jordan D. Hailer, "An Introduction to the Food and Drug Administration andHow It EvaluatesNew Dev~ces:Establishing Safety and Efficaq," in Cardiovascular and InterventionalRadiology.

In t h s case, thethird party will perform a mdormance assessment for the device mandacturer and provide the manufacturer witha statement tothis effect. The marketing application should then includea declaration of conformity signed by the manufacturer, wtulethe statement h m the thud party should be maintained in the Device Master Record. As always, responsibility forconformance with design control requirements rests withthe manufacture. In order to provide an incentive for manufacturerschoose to this option, the office of Device Evaluation(ODE) intends to process Special 510(k)s withrn 30 days of receipt by the Document Mail Center.

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