EMC 4th Edition Basics and Risk Management (RMF) Requirements

The fourth edition of IEC 60601-1-2 includes a number of dramatic changes, including more robust risk analysis requirements. FDA is recommending electromagnetic compatibility (EMC) testing to IEC 60601-1-2 4th Edition standards, requiring manufacturers to submit test plans and risk analysis documents before testing.

FDA Cybersecurity in Medical Devices

Intertek’s global cybersecurity experts present a webinar on the “FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”