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 ...

Designed to address the needs of users and patients. Designed to meet inputs and requirements. Proven to meet applicable standards. Meets performance criteria. Realize Design Controls and Risk ...

FDA's quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the ...

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 ...

Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...

Batch remains advantageous for development, variable demand, and bounded risk, benefiting from natural hold points, simpler investigations, and lower upfront capital, despite longer lead times and ...