by Steve Donnigan | May 26, 2026 | Regulatory & Risk Management
The “Green Program” That Wasn’t Three months before formal verification, the program review looked exactly as leadership would hope. Every major workstream was green. Milestones were holding. No critical issues were open. The dashboard signaled control. The first full...
by Steve Donnigan | Apr 17, 2026 | Regulatory & Risk Management
The Risk Analysis Paradox In regulated product development, risk analysis is one of the most formalized engineering activities. Hazard analyses are created, risk matrices are populated, and mitigation tables are carefully maintained. Yet many design problems...
by Steve Donnigan | Feb 12, 2026 | Regulatory & Risk Management
Designing a medical device that performs beautifully isn’t enough. It also has to meet the world’s toughest regulatory and safety standards. In 2026, compliance is more than just a checkbox, but, rather, a competitive advantage. Teams that integrate regulation...
