Full Description

This document describes a method to be followed when a customer complaint may be a reportable event in Europe. This procedure also provides instructions for deciding whether to report the event, to which Competent Authority, the reporting time limits, and the actions to be taken. Attachments include flow chart of actions, initial incident report form, and final report form. This procedure adheres to Medical Device directive (93/42/EEC). See 09-0179-SOP-1.0 for US reporting procedure.

Product Details:

Edition: 1 Published: 11/01/2004 Number of Pages: 11