The Center for Biologics and the Center for Drugs has issued a final guidance for the submission of labeling in electronic form for FDA review. (Note: it does not pertain to electronic labeling provided to users).
SoftwareCPR keywords: Blood Bank, electronic submission, online submission
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.
