On a recent podcast of Quality Injection Podcast EP12, our General Manager Brian Pate spoke with Oded Assouline on the topic of US FDA Design Controls and in particular Design Input.  Some of the questions they explored were Is a concept phase needed for defining the product or device that meets the user needs. Are validation...Read More

Clearly one of the great struggles with medical device product design is to understand and finely tune the design input for our devices.  It is difficult but the payoff can be great when done well – pays off with development efficiency, greater certainty with safety risk control, and ultimately in customer satisfaction. In our training...Read More