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With the EU MDR, the requirements for the labeling of medical devices are changing again. Different legal requirements and partly impermeable framework conditions make it difficult for manufacturers to create a uniform and compliant labeling for the products.
In this seminar, the connection between the different requirements for labeling and their relationships will be explained step by step. This helps to define the newly required minimum information for the safe use and traceability of the products, as well as to discover any new safety or performance-related information for the user or third parties, if applicable.
topic overview
- What does labeling include?
- Regulatory labeling requirements
- IFU
- product label
- Unique Device Identification (UDI)
- Interfaces to the most important processes
target group
Employees in quality management or regulatory affairs, developers, marketing managers.
previous knowledge
Not mandatory.
KONTAKT:
MedicalMountains GmbH
