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eBook: Agile in an FDA Regulated Environment

The medical device industry is facing unprecedented challenges due to emerging technologies and increased regulatory scrutiny.

Current “waterfall” product development methods are ill-suited to dealing with the pace of change and uncertainty that product development organizations are facing. This eBook addresses:

  • The shortcomings of waterfall development specifically in regulatory environments.
  • How agile development meets the safety, reliability and regulatory needs of the medical device and diagnostics industry.
  • How agile development can help ensure delivery of successful software.
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