FDA Quarterly MDR Reporting Pilot Program

FDA is initiating a pilot program that would allow quarterly reporting of MDRs for certain Class I and Class II devices in situation that do not reult in death or serious injury or a correction is not needed to prevent this. Companies can apply to participate in this pilot as indicated in the FDA announcement at the link provided.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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