Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

Abstract: Resource-efficient and robust validation of systems designed to measure a multi-dimensional parameter space is an unsolved problem as it would require millions of test permutations for ...

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices' safety, efficacy, and quality. The agency has developed a rigorous medical device ...

In the first months of his administration, President Donald Trump repeatedly threatened due process, a fundamental principle enshrined in the U.S. Constitution. His attacks have spanned from the ...

Psychologist, author and adjunct instructor at Stanford University Caroline Fleck, PhD, has a new book out entitled Validation: How the Skill Set That Revolutionized Psychology Will Transform Your ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

Caroline Fleck is a clinical psychologist with expertise in dialectical behavior therapy (DBT), a treatment for borderline personality disorder. According to Fleck, DBT was the first behavioral ...

Abstract: Example sentences serve as a crucial bridge for learners to master language application rules, enhance language skills, and develop a sense of language. These sentences encompass various ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

If you see the error “This value doesn’t match the data validation restrictions defined for this cell” when entering a value in an Excel cell, the solutions ...

Christy Bieber has a JD from UCLA School of Law and began her career as a college instructor and textbook author. She has been writing full time for over a decade with a focus on making financial and ...