Navigating FDA 60601-1 Compliance for Medical Devices

For years the US Food and Drug Administration has mandated that medical devices comply with 60601 standards for near-patient safety, and while that’s great for patients, it can be a difficult or frustrating road to navigate for medical device manufacturers.   60601-1 ratings are given to devices…


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Protect Yourself with True Medical Computer Certification

It's likely you've read about the IEC 60601-1 medical certification here before, but previous topics haven't detailed the specifics behind safety and why that matters for a hospital and its patients. If a computer isn't 60601-1 certified, there are complicated hazards than what might appear on a…


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