With the increased complexity of devices, a streamlined approach to managing product development risks and documenting compliance is challenging but perhaps more important than ever.
As medical device complexity grows, the product development process often needs to improve in order to maintain device quality and safety, foster innovation, and reduce costs. Yet teams looking to make improvements often encounter resistance from management. This Ask the Expert focuses on how you can overcome barriers to improving the medical device development process.
Part I in a series of articles that will provide insight into TSP, its applicability to the medical device industry, and how it helps achieve the high level of software quality required for devices.