MedicalMountains GmbH Change management: documentation and traceability

target group

Medical device manufacturers, QM/QA managers, change managers, purchasing and supplier support as well as production managers.

content

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

previous knowledge

Prior knowledge of quality management and the manufacture of medical devices is recommended, but not mandatory.

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