For years, medical device manufacturers in the U.S. have operated under the FDA’s Quality System Regulation (21 CFR Part 820), often alongside ISO 13485 to meet global requirements. With the FDA’s move to align its regulation with ISO 13485 under the new Quality Management System Regulation (QMSR), that separation is going away.
For many small and midsize manufacturers, the idea of implementing a Manufacturing Execution System...
Manufacturing has never been static, but the level of uncertainty today feels different.
Trade...
Inventory is one of the most visible (and misunderstood) parts of a manufacturing operation.
Too...
Late deliveries rarely come from a lack of effort. Most small and midsize manufacturers work hard,...
Manufacturing software doesn’t fail because the technology is bad. It fails because it’s...
For aerospace manufacturers, quality standards are nothing new. Compliance has always been part of...
Production supervisors live in the middle of everything. They’re responsible for schedules, people,...
The skilled labor gap isn’t a future problem. It’s already here.
Small and midsize manufacturers...
Automation has been part of manufacturing for decades. Robots load parts. Machines run unattended....
Most manufacturing errors don’t start with bad intent or poor workmanship. They start with missing,...
For small manufacturers, competition with larger shops can feel uneven from the start. Bigger...
Manufacturing Execution Systems (MES) have been around for a long time. Yet for many small and...
In a year defined by uncertainty, preparation, and progress, manufacturers were searching for...
If manufacturing had a “wrapped” this year, it wouldn’t be defined by flashy buzzwords or big...
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