Does a Change to a Medical Device Require a New 510(k)?
Medical devices rarely stay the same after they receive clearance from the FDA. New breakthroughs, design tweaks, software updates, and manufacturing improvements happen all the time....
Do Wellness Devices Need FDA Approval?
Wellness devices do not require FDA approval or premarket clearance if they promote general wellness or healthy activity and present a low risk to users without...
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....
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...
How Manufacturing Process Controls Affect Medical Device Compliance
At MedLaunch, we see manufacturing process controls as a direct link between product quality and regulatory compliance. A strong design can still run into trouble if...
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