Introduction — a question that starts the conversation How many good products have you seen stalled at the last gate because someone missed a test? In my work I assess medical device testing services every week, and I can point to data that shows delays are common — studies indicate regulatory hold-ups affect roughly 20–30% of submissions in certain device classes (Class II devices often top that list). I write as someone with over 18 years advising manufacturers and running lab programs; I’m speaking to regulatory affairs managers and product engineers who need clear, usable advice. Picture a small team in Raleigh, NC in November 2019; we had a sterile…