In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...

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 ...

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 ...