Agile in an FDA Regulated Environment

The medical device industry is experiencing unprecedented opportunities and challenges created by emerging technologies and increased regulatory scrutiny. Shifting paradigms from legacy software engineering approaches to agile software development is a must-do for medical device manufacturers. This eBook addresses how Agile development can be adapted to meet the safety, reliability and regulatory needs of the medical device, pharmaceutical and diagnostics industries, and how it can accelerate the development of successful software-based devices.

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