Under the Watchful Eye of the FDA: What do FDA Warning Letters Tell Us?

Kevin L. Ong, Ph.D., P.E.1; Joshua White, Ph.D.2 1 Principal Engineer, Biomedical Engineering practice, Exponent, Inc., Philadelphia, PA 2 Senior Associate, Biomedical Engineering practice,...

What are design controls and why are they important?

Question: What are design controls and why are they important? Answer: “Design controls” is a broad term that describes several procedures and processes used throughout the design and...