As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF):
• “AI-enabled device software functions—Life cycle management and marketing submission recommendations” (draft…

Tom Taormina, esteemed quality consultant and long-time contributor to Quality Digest, has passed away. He is survived by his wife, Midge, and their three children. Recently, Taormina was working with Quality Digest and a consortium of others to design a certified training program for quality professionals, called “Quality Master,” a five-level program to address the future needs of the…

I heard an interesting twist on an old question the other day. People always ask the classic, “What keeps you up at night?” question. (By the way—don’t ever ask that of your interviewer during a job interview. It comes across as cheesy and stupid.) But while the question itself is a little corny, the notion behind it is interesting and points to a dark set of issues.

It’s…