Blogs by Jeramie

The medical device industry doesn’t fail because teams “don’t know enough.” It fails when teams can’t execute under pressure—on the floor, in supplier quality, in CAPA, in audits, and during complaint investigations—where mistakes create regulatory risk, scrap/rework, and patient safety exposure. This issue is reshaping MedTech as we speak.

Content drawing from real-world experience in regulated industries, quality systems, and professional insight.

Every product tells a story—but not every story should go to market. That’s where we come in. As a product release quality reviewer, I’ve stood at the final gate between manufacturing and the patient. It’s a role most people don’t notice—until something goes wrong. But when it’s done right, it prevents recalls, protects reputations, and—most importantly—saves lives.