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David Vogel, author of the book, Medical Device Software Verification, Validation, and Compliance, discuss the motivation behind his title.
There is a tendency for many in the medical device industry to be driven by regulatory concerns and checklists when validating software. Many have a âtest onlyâ perception of validation for the final days or weeks of a development project. Corporate management is perplexed with the costs of validation, and disturbed when defects are only discovered once the product is released. Many ask why validation seems to slow down product development, at great cost, yet allows defects to reach the customer or patient. It doesnât have to be this way. Read More
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