It’s important to consider packaging design early on during the medical device product design process, according to Jenn Goff, director of product marketing of Oliver Healthcare Packaging. During the ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Bioprocessing is an umbrella term that describes the research, development, manufacturing, and commercialization of products derived from or used by biological systems. For industrial purposes, ...
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 ...
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 ...
In process automation, an alarm is defined as an audible and/or visible means of indicating to the operator an equipment malfunction, process deviation, or abnormal condition requiring an operator ...