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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
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
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
CDRH: Updated Draft Guidances – 510(k) Program
October 30th, 2023 – Written by Mitchell Gorthy Summary On October 26th, the FDA’s Center for Devices and Radiological Health (CDRH) updated draft guidances to
Medical Device Software Guidance
October 24th, 2023 – Written by Mitchell Gorthy Overview MDCG has updated guidance on medical device software (MDSW) intended to work in combination with hardware
“Regression Analysis”, How to test for unintended consequences in your corrective actions
By Mauricio Rodriguez – Think about it this way; when you change something what else could be impacted by the change? Could the change also have some other unintended consequences? This is equivalent to a “regression analysis” in software, here is how to do it for your medical device.