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
Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software. Planning, requirements, validation, and submissions – we can assist with all.
Interested in having a conversation? Email us to arrange a Zoom meeting or call us at +1 781-721-2921.