Safe Integration of Electrical Safety and Software in Medical Devices

Gustav SundströmSenior Consultant, Medical Device Quality Assurance – GBA Key2Compliance AB The medical device industry holds patient safety as a top priority, but as devices grow increasingly complex, ensuring their safety demands more than just careful design—it requires a comprehensive approach. Today, medical devices rely heavily on both electrical safety mechanisms and medical device software […]

Free webinar: Is your medical device software MDR ready?

There are lots of great ideas and products related to medical device software today. Many of them already are compliant to the Medical Devices Directive (MDD), others are in an earlier development state. Since May 26th, 2021, the Medical Devices Regulation (MDR) is in force and latest May 26th, 2024, all medical device software has […]

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