Before shipping to manufacturing.
Configuration identification, change control, and status accounting. Iec 62304 Checklist Xls
Deep in the heart of a bustling tech hub, a small medical device startup named VitalPath was on the verge of a breakthrough. Their innovative software, designed to monitor cardiac health in real-time, had the potential to save countless lives. But there was one major hurdle standing between them and the market: regulatory compliance. Before shipping to manufacturing
25, 12.1, "Document control", Documentation, "Ensure controlled documents: versioning, approvals, distribution", "Document register, document control procedure", "Documents current and archived", Not Started, Document Controller, , , Low, "Ensure controlled documents: versioning