If you are developing a medical device for the U.S. market, you first need to determine how your device will be classified by FDA. If you do not know the FDA classification, I recommend you go check ...

Medical device manufacturers have a bit of latitude in developing a design control system as long as they meet the minimum criteria delineated in the quality system regulation (QSR). The QSR states ...

Design Reviews are intended to be checkpoints in a medical device product development to ensure the product design is safe, effective, and progressing. Design Reviews are also a way to ensure Design ...

Identifying constraints explicitly in the design-input document facilitates project management and reduces risk. by Gerald E. Loeb and Frances J. R. Richmond Figure 2. Display window containing ...

Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design ...