of December 2019
Location: Germany, Stuttgart area
Costs: Regular € 875.-
Qserve Group Germany GmbH offers you a hands-on course on the current
requirements for labeling, unique device identification and product information
/ instructions for use of medical devices under the aspect of the up-coming European
Medical Device Regulation.
Note: this training can also be provided in-house for
other organizations in the supply chain involved in one or more
stages of the life-cycle of a medical device, including design and development,
production, storage and distribution, installation, servicing or provision of
associated activities. The contents will be adapted to the specific role(s) of
- To understand the practical
impact of the changed requirements for labeling according ot the European
Medical Device Regulation
- To be able to implement
required changes and generate and maintain the documentation required to
achieve market access for the developed device
- To learn from real life
examples how requirements can be fulfilled following a practical approach.
- Labelling Standards: How to properly label your
- Unique Device Identification: What needs to be
considered in the future
- Essential contents of the user manual considering the
- Liability for incorrect or incorrect product
Legal requirements and normative requirements for
labeling & product information
Traceability obligation & implementation
Practical Guide to Labeling Medical Devices
Instructions for Use Medical devices
Questions and Answers
attend this course?
R&D, Marketing, RA and Business Development
personnel working at a medical device manufacturer, who are involved in the
development of labelling materials for medical devices.
Personal Certificate of Attendance.