An Overdue Correction: Who Actually Owns the Quality Management System
In nearly every training session I hold, I ask the same question: who is responsible for quality in this organization?
Management Systems, Standards
Notes
The Hardest Project I’ve Ever Managed
On July 23, 2025, I got a call that made me cancel every meeting on my calendar. What followed became the hardest project I’ve ever managed — and I finished it.
When Your Supplier Hands Your Drawings to an AI
Suppliers are quietly using AI tools to draft procedures and protocols from customer drawings and specifications. Here’s what that puts at risk — confidentiality, export compliance, and product quality — and the controls both customers and suppliers should have in place.
Artificial Intelligence, FDA 21 CFR 820 QMSR, ISO 13485, ISO 42001
AI Tools in Medical Device Manufacturing: A Roundtable with Art Meta, Norma Tive, and Clara Fication
We pulled three of our resident experts into one (virtual) room to tackle the five AI questions medical device manufacturers are wrestling with right now. There was banter. There were citations. Norma kept her composure.