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 ...

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 ...

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, ...

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 ...

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 ...