Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

The purpose of the design and development plan section is to provide investors with a description of the product’s design, chart its development within the context of production, marketing, and the ...

Last month, this column explored the best time to functionally test new systems. This month and next month, I want to back up and talk about the best time to prepare the functional performance test ...