Description
This document describes a method for collecting information regarding reportable events and filing the required reports for marketed medical devices. This procedure is specific for reporting to the FDA. This SOP adheres to 21CFR, Part 803. See 09-0178-SOP-1.0 for European reporting procedure.
Product Details
- Edition:
- 1
- Published:
- 11/01/2004
- Number of Pages:
- 5
- File Size:
- 1 file , 110 KB
