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Once the conformity assessment for a medical device has been positively completed, it is necessary to secure and document the documented conformity with the basic requirements for legacy devices or the basic safety and performance requirements - including the changes that have to be made over time . Appropriate change management is essential for this.
The seminar imparts the theoretical basics of change management for Europe and the USA and presents tried-and-tested procedures for practical implementation within the framework of quality management, from document control to traceability of the status of products.
topic overview
- Legal and normative foundations for change management
- Document control, design control
- Change management: design changes
- Change Management: Changes in manufacturing processes
- Specification and verification documentation (archiving)
- Identification and Status
- traceability
- Unique Device Identification (UDI)
- Possible impact on the declaration of conformity
target group
Medical device manufacturers, QM/QA managers, change managers, purchasing and supplier support as well as production managers.
previous knowledge
Prior knowledge of quality management and the manufacture of medical devices is recommended, but not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online