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.
Despite a clear need to get better development lifecycle management solutions in place, companies are restricted by tight budgets, validation overhead, and bureaucracy. In this Q&A, Matt Harp and Angie Pepiot at Seapine Software share their insights.
This week’s guidance is all about the manufacturing control of sterile medical devices, validation, and more validation.