Monthly Archives: September 2024

Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

Embracing the Future: The FDA’s Guidance on AI in Medical Devices As we enter an exciting era of technological advancement, the role of artificial intelligence (AI) in medical devices stands out as particularly transformative. The FDA’s recent guidance on “Good … Continue reading

Posted in EN 60601-1, FDA, Medical Devices Regulation (EU)2017/745 | Comments Off on Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

What is an NRTL Field Label and What do I Need to Know About Them?

If an Authority Having Jurisdiction (AHJ) or electrical inspector has ever informed you that you have failed your inspection or that you require a “UL or CSA Certification” or that your equipment must be “UL/CSA Certified” or “UL/CSA Labeled” we … Continue reading

Posted in Field Label, Product Testing, SPE-1000, US Field Label | Comments Off on What is an NRTL Field Label and What do I Need to Know About Them?