MDR labelling and UDI

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TRAINING

MDR Labelling and UDI

Qserve Group Germany GmbH offers you a hands-on course on the current requirements for labelling, unique device identification and product information / instructions for use of medical devices under the aspect of the up-coming European Medical Device Regulation.

 

 

 

 

Learning objectives

  • To understand the practical impact of the changed requirements for labeling according to the EU MDR
  • 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

Focus points

  • Labeling standards: how to properly label your medical device
  • Unique device identification: what needs to be considered in the future
  • Essential contents of the user manual considering the user
  • Liability for incorrect or correct product information

Program overview

Program

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

Who should 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

Costs

We offer open enrolment, on-location, train-the-trainer formats.

Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.

Costs: € 875.- p/p for a one-day training

How can we help you? Contact us