Training

Public Training: MDR - Labelling and UDI Implementation

December 09, 2019

Date: 9th of December 2019

Location: Germany, Stuttgart area

Language: English

Costs: Regular € 875.-

Introduction

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 that organization.

Learning objectives

  • 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.

Focus points:

  • Labelling 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 incorrect product information

Program overview:

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.

Certification:

Personal Certificate of Attendance.

Trainer:

Stefan Menzl
Post date: May 13, 2019
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