R&D

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 [...]

Medical device regulation gets more stringent all the time. It’s harder to get FDA approval now than it was just five years ago. For good reason.

Geometric dimensioning and tolerancing (GD&T) is intimidating even for trained engineers to pick up. GD&T has a set of vocabulary that is initially impenetrable and throws out a lot of [...]

No matter how precise the manufacturing process, there will inevitably be some degree of variation in the components that make up your medical product. All the parts that comprise the finished [...]

Medical device development is full of regulatory hoops and documentation. Unfortunately, it’s all too easy to view some of the requirements as little more than “paperwork.” The use [...]

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 [...]