Description
This document defines which changes to the Quality System and/or Product Design require approval from the Notified Body (Europe) pior to implementation, and it also explains the strategy toward voluntary notification of changes that do not require further approval of the notified body but that are neverhteless notified because of their importance. A change management flowchart is included. This document adheres to Medical Device directive 93/42/EEC.
Product Details
- Edition:
- 1
- Published:
- 11/01/2004
- Number of Pages:
- 3
- File Size:
- 1 file , 67 KB
