The FDA published instructions and an example for application of the ICH electronic common technical document for the regional FDA related portions for submissions. Full infomation is at the link provided.
SoftwareCPR keywords: eCTD
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.