Do Wellness Devices Need FDA Approval?
Many wellness technology brands ship products every day without a single FDA submission. Others in the same category face warning letters and recalls. The difference comes...
How Does IEC 60601 Fit Into an FDA Submission Strategy?
IEC 60601 plays a central role in your FDA submission strategy for any device with electrical or electronic parts. The FDA recognizes IEC 60601 as a...
What Is Medical Device Shelf Life and How Is It Validated?
Every medical device has a clock running. Shelf life tells you how long that device stays safe and performs as intended before it should be discarded....
How Do You Know If Your Medical Device Is Ready for FDA 510(k) Submission?
You have spent months on design, testing, and documentation. Now comes the hard question: is your device actually ready to file? For Quality Assurance managers and...
What Are the Biggest Compliance Risks for AI Medical Devices?
AI-powered medical devices open new doors for diagnosis, monitoring, and treatment. They also bring compliance risks that traditional software simply does not have. If you lead...
What Documentation Is Needed for IEC 62304 Compliance?
Building medical device software comes with a clear set of expectations. IEC 62304 defines the software lifecycle processes you need to follow, and most of those...
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