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 […]
IEC 60601 – Meeting the Electrical Safety Standards of Medical Devices

Read and learn more about IEC 60601 and IEC 61010, and the factors you should consider when developing a regulatory-compliant medical device. Electrical devices are part of our everyday lives, and they are undoubtedly cornerstones of our society and technology – this applies to the industries of life sciences and medical technology as well. However, […]
Meet Gustav Sundström, one of our electrical safety experts!

What you need know about electrical safety for medical devices according to the IEC 60601-series Electrical safety in medical devices is very important to ensure the safety of both patients and caregivers. The regulatory world of medical electrical devices can seem complex at times, especially with the transition to MDR and its new requirements. But, […]