A New Approach to Verifying and Validating Medical Device Development

A New Approach to Verifying and Validating Medical Device Development

Cover

The list of features in medical devices is rapidly rising: Even the simplest of medical devices—such as diagnostic and monitoring systems—house more and more system components, which add greater functionality to the device at a low cost. But by adding components, device software becomes complex and burdens compliance testing and premarket certification activities, such as 510(k) submissions mandated by the U.S. Food and Drug Administration (FDA).

Vendor:
IBM
Posted:
13 Dec 2010
Published
13 Dec 2010
Format:
PDF
Length:
12 Page(s)
Type:
White Paper
Language:
English
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