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 ...

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 ...

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 ...

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 ...

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 ...

The new ProductDesign Controls module gives companies the ability to improve design control processes and unify documentation while ensuring both FDA and ISO regulatory compliance. Users are able to ...

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 ...