Evaluator

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 [...]

The medical device industry is highly regulated. For good reason. These regulations exist to protect patients and consumers by ensuring the safety and efficacy of medical devices. Of course, [...]

If you’re considering partnering with an agency to help you realize your vision for a new medical device, you already know you need outside expertise for the design phase of your project. But [...]

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 [...]