Enerxen

Enerxen
Enerxen

Medical Device Regulation

AI/ML Enabled Medical Devices

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FDA and Enerxen company logo, over a picture of an AI data block.

December 13th, 2023 AI/ML Enabled Medical Devices Overview Artificial Intelligence (AI) encompasses the science and engineering behind creating intelligent machines and programs. Techniques in AI range from statistical analysis models to expert systems reliant on if-then statements and Machine Learning (ML). ML, a subset of AI, involves training software algorithms to learn from large sets … Read more

Software Security Standards

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November 20th, 2023 – Mitchell Gorthy FDA recognizes three new international medical device software security standards The FDA and CDRH recognized three new medical device software security standards. ANSI/AMMI 2700-2-1 and ANSI/AMMI SW96 developed by American National Standards Institute (ANSI) and The Association for the Advancement of Medical Instrumentation (AAMI) are among them. ISO/IEC/IEEE 29119-1 … Read more