Medical device product development is a highly integrated and regulated process. Implementing requirements management, risk management and mitigation requires attention to a variety of nuanced topics. Next-generation agile engineering solutions include tools that address the key challenges in developing and certifying medical devices for commercial use.
Check this white paper which provides an overview of the nuances of requirements management, risk management and mitigation, and highlights the shortcomings of traditional tools to address these challenges to provide a solution for the complex nature of medical device manufacturing.
