Uncategorized

For nearly 30 years, the medical device industry has relied on the QSR (21 CFR Part 820). On February 2, 2026, that era ends. The FDA’s transition to the Quality Management System Regulation (QMSR)—harmonizing with ISO 13485:2016—isn’t just a “paperwork update.” It is a fundamental shift in how the FDA expects you to manage risk, […]

If you are looking at your 2026 insurance renewal and seeing double-digit increases, you aren’t alone. But here is the secret most brokers won’t tell you: The “General Risk” bucket is costing you a fortune. When an insurance carrier evaluates an industrial site, they default to “high-risk” premiums unless you can prove otherwise. If you

As we enter 2026, the enforcement landscape for New Jersey manufacturers has shifted. With OSHA’s National Emphasis Programs (NEPs) now aggressively targeting warehousing, chemical handling, and heat illness prevention, the “standard” internal safety walk-through is no longer enough. If your safety team is checking their own work, they may likely suffering from institutional blindness. You