Content
After the conformity assessment for a medical device has been successfully completed, it is necessary to secure and document the conformity once achieved and documented with the basic requirements for legacy devices or the basic safety and performance requirements - including any changes that may become necessary over time . Appropriate change management is essential for this.
The seminar conveys the theoretical foundations of change management for Europe and the USA and presents tried-and-tested procedures for practical implementation in the context of quality management, from document control to the 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 to 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/QS managers, change managers, purchasing and supplier support as well as production managers.
Prior knowledge
Previous knowledge of quality management and the production of medical devices is recommended, but not mandatory.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
