Mitchell Gorthy 
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
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
November 7th, 2023 – Written by Mitchell Gorthy CE Marking: Overview The European Union (EU) uses the CE marking as a conformity mark to indicate that a product or device complies with EU health, safety, and environmental protection requirements. It signifies that the manufacturer has taken the necessary steps to ensure their product’s conformity with … Read more
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 modernize their 510(k) program. Employees from the CDRH’s Office of Product Evaluation and Quality gave brief overviews of each draft guidance. Regulatory Advisor, Megha Reddy, explained “Best Practices for Selecting … Read more
October 24th, 2023 – Written by Mitchell Gorthy Overview MDCG has updated guidance on medical device software (MDSW) intended to work in combination with hardware or hardware components. MDSW integrations within medical devices are increasingly relevant in recent years. With increased accessibility to smart-devices (e.g. smartphones, smartwatches, tablets, etc.) the availability of information for patients … Read more