These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

We are living in an unprecedented era of rapid medical innovation in the face of COVID-19. The speed of development for devices and diagnostics has been driven by the urgency of the pandemic resulting ...

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 ...

As I discussed in a previous article about how to bring a medical device to market in the United States, Gartner projects nearly $8 billion in spending on sports watches and wristbands by 2021. This ...