P1.2 Prescribing direction

To avoid common design decision pitfalls and safeguard your medical device’s usability, read this whitepaper. You’ll learn how to prevent the four biggest missteps in the first place and see how [...]

Medical devices are increasingly built around software. Of course, almost any medical device with a battery or power cord has a software component of some kind. But as more and more tech [...]

Even though the risk management process is continuous, you can break it down into steps to make it more manageable for you and your team. Let’s explore the steps that should happen after you’ve [...]

Risk management is a crucial aspect of medical device development. You need to account for and mitigate the risks associated with your product early on, so it’s safe for users and passes [...]

The FDA requires user interface specifications for medical devices. But your user interface specification can and should be more than a requirement or regulatory box to check.

From a medical device development perspective, the goal of human factors engineering, usability, and user experience activities is the same: To release a product that meets users’ needs in a [...]