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 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