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 ...

When it comes to process-control systems, reliability is crucial and failure can be costly or dangerous. A combination of good design practices, component selection, and testing can enhance ...

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 ...

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 ...

With the continued need for shrinking pattern dimensions, semiconductor manufacturers continue to implement more complex patterning techniques, such as advanced multi-patterning, for the 10nm design ...

Participate in our immersive 2-day virtual seminar to acquire essential knowledge and establish robust processes for Design Controls in the production of safe and effective medical devices. Recognized ...

I recently surveyed the on-site development of the control system for a large concentrated solar power station. This “first of a kind” facility offered many control challenges, such as balancing heat ...

The process control and instrumentation minor emphasizes developing skills and knowledge in theory, software and in the field. Students graduate ready to solve complex control problems in the chemical ...

A Protection and Control (P&C) design package for a typical substation includes a number of interrelated drawings, including one-line diagrams, schematic diagrams, wiring diagrams and interconnection ...

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 ...