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.
Document identifier
DOXPUB 09-0180-SOP-1.0
Title
EC Notification of Change Procedure
DOXPUB Category
Regulatory Affairs
Publication date
2004-11-01
International Relationship
Latest version
DOXPUB 09-0180-SOP
History of version
DOXPUB 09-0180-SOP*DOXPUB 09-0180-SOP-1.0 * DOXPUB 09-0180-SOP * DOXPUB 09-0180-SOP-1.0
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DOXPUB 09-0180-SOP-1.0
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