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The FDA review process can be one of the most intimidating parts of developing and manufacturing a new medical device. You’ve invested time, money, and momentum into your product. You may even have strong early data or a working prototype. But then you hear stories of devices getting stuck, delayed, or outright rejected during FDA review, and suddenly…

In the medical device field, you must demonstrate, test, and document via a protocol supported by your quality management system (QMS) meeting ISO 13485 requirements. You do so by creating protocols (IQ, OQ, PQ), which are methods to demonstrate that the equipment being installed or used gives you a high degree of assurance that production processes will consistently manufacture products that meet quality…

If you are developing a medical device, one of the first regulatory questions you need to answer is: What class is my device?  The FDA classifies medical devices into three categories based on risk to the patient and the level of regulatory control needed to ensure safety and effectiveness. These classifications affect everything from testing requirements to…

If you discover your scrap rate is creeping up, you’re probably having these two thoughts at once: What’s the cause? and How can I eliminate the cause quickly? We’ve seen teams burn weeks chasing the wrong “obvious” cause because they “didn’t have time” to organize a clean approach to narrow it down and ended up…

The medical device industry has entered a new regulatory phase as the FDA transitions from the long-standing Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR). This change took place on February 2, 2026, and aligns with U.S. requirements more closely with ISO 13485:2016, the globally recognized standard for medical device quality management systems.   Because of this…

Medical device manufacturers operate in one of the most highly regulated industries in the world. Quality systems govern how devices are designed, tested, manufactured, and monitored after release. For decades, companies selling devices in the United States followed the FDA’s Quality System Regulation (QSR), 21 CFR Part 820.   As of February 2, 2026, that regulatory…

Some of the smartest engineering teams still miss deadlines, blow budgets, and struggle to finish the work their stakeholders are counting on. It can be frustrating because the engineering talent is there, but the project results don’t reflect that talent.  From my experience, many of these problems could be avoided, or at least reduced, with strong project management on the team. Below is a little more about what I’ve seen go wrong on projects, and how to get…