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atsec AB first IEEE 2621 Accredited Medical Device Testing Facility
atsec AB Stockholm, Sweden is thrilled to announce: We are the first IEEE Authorized Testing Facility! We’ve officially been approved as an IEEE Authorized Testing Facility, making atsec AB Stockholm, Sweden the first company able to provide testing of medical devices according to the IEEE 2621 standard. Additional…
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Cybersecurity Requirements for Medical Devices
On September 26, 2023, The Food and Drug Administration (FDA) released their finalized Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance document. This document provides general principles for device cybersecurity relevant to device manufacturers. It seeks to emphasize the importance of safeguarding medical…
