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Physical and digital therapy is converging into a new breed of treatment proven to increase the efficacy of traditional therapies – and in some cases - outright replace traditional therapies. There is no question this software is life-changing however the Product Development Lifecycle for medical software, especially for mobile devices, is different than hardware devices or drug molecules.
Join Sanofi and Rightpoint Health and learn how to navigate the complex and unique space of medical application development including:
- The requirements for building FDA-regulated digital therapeutic software
- Medical Software device classification (Class 1 Exempt, Class 2, Class 3)
- Specific approaches to software development that meet regulatory requirements for a medical device (even though the device is purely software)
- Role of Human Factors studies in the development process
- Medical domains already using regulated mobile application development and where we expect to see future adoption of this technology.