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

AI/ML Enabled Medical Devices

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

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Software Security Standards

November 20th, 2023 – Mitchell Gorthy FDA recognizes three new international medical device software security standards The FDA and CDRH recognized three new medical device

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Enerxen logo, EU union logo, and CE marking, displayed over foggy mountain range. Title: Demystifying CE marking for non-eu companies.

CE Marking

November 7th, 2023 – Written by Mitchell Gorthy CE Marking: Overview The European Union (EU) uses the CE marking as a conformity mark to indicate

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