Evaluator

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 [...]

Whether you’re developing a new medical device or updating an existing one, you already know that your success hinges on your product’s user experience. A well-designed, user-friendly device can [...]

Prototypes are the cornerstone of medical device development. They are powerful and important tools that transform ideas, thoughts and theories into something real. Prototypes also become a [...]

The process of developing a new medical device is overwhelming. The sheer volume of logistics and requirements makes it extremely challenging to anticipate and plan for each of the many steps [...]

The business of introducing new medical devices requires us to address enormous technical challenges that require plenty of hard work. As we strive to meet these challenges, the FDA reminds us [...]

For many companies, the first step in producing the right medical device is hiring the right design and engineering partner. In fact, hiring the wrong one can be catastrophic. The [...]