R&D

Nothing about launching a new medical device is simple. From the FDA’s regulatory requirements to usability testing, medical device development can seem downright byzantine. Unfortunately, the [...]

Medical devices are often entirely custom, but what happens when you don’t want to get into the business of making a custom display? Or a computer? These electronic devices have to conform [...]

Developing a medical device first requires defining precisely what that product is supposed to do. Discussion among stakeholders often elicits vastly divergent ideas. The challenge here is for [...]

In your quest to design a user-friendly, software-driven medical device, you likely plan to spend the lion’s share of your time and attention on, well, the software. Make no mistake, the quality [...]

If you’re planning to bring a new medical device to market, your first order of business is to determine how your product will be classified by the Food and Drug Administration. As you likely [...]

If you’re thinking of bringing a new medical device to the market, you probably already know that your first step is to determine whether or not you need to follow the FDA’s Design Controls. If [...]