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.
Document identifier
DOXPUB 09-0178-SOP-1.0
Title
Medical Device Reporting Europe
DOXPUB Category
Regulatory Affairs
Publication date
2004-11-01
International Relationship
Latest version
DOXPUB 09-0178-SOP
History of version
DOXPUB 09-0178-SOP*DOXPUB 09-0178-SOP-1.0 * DOXPUB 09-0178-SOP * DOXPUB 09-0178-SOP-1.0
| Price |
220 vnd |
DOXPUB 09-0178-SOP-1.0
.jpg){kind=logo}
---Logo.jpg){kind=logo}
.jpg){kind=logo}
-_-logo.png){kind=logo}
.jpg){kind=logo}
.png)
