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 ...

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 ...

Medical device manufacturers have a bit of latitude in developing a design control system as long as they meet the minimum criteria delineated in the quality system regulation (QSR). The QSR states ...

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, ...

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 ...

Perhaps the most important message of the guidance is implied, rather than stated. By explicitly emphasizing the use of risk-benefit determinations in the product approval process (even if for a ...

Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in the ...

DUBLIN--(BUSINESS WIRE)--The "Quality by Design - Essential Techniques for Medical Devices" conference has been added to ResearchAndMarkets.com's offering. Course "Quality by Design - Essential ...

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 ...