Open Training: MDR Transition

März 19, 2019 - März 19, 2019 / Europe

Date: 19 March 2019

Duration: 1 Day 

Location: Amsterdam, The Netherlands

Language: Presentations will be in English

Cost: Regular  € 875.-

*You get 10% early bird discount if you book latest by 18th of February 2019 

Introduction 

The new EU-MDR brings about many changes, including many definitions, reclassifications, new conformity assessment routes, new notified body designations and more. Stricter requirements on safety of ingredients, on clinical evidence and on consistency in regulatory compliance. Much more detailing in the essential principles, and above all: no grandfathering.

The training will discuss the options available for the transition from MDD to MDR, it will highlight timelines, resources, Notified Body approach, and the top 10 changes for technical documentation. This training focusses on practical guidance to implement the gaps assessments needed for dossiers, QMS and perhaps specific for clinical. It will provide details on product portfolio review, and on determining the impact of the regulation. High-level project planning will be included. The day will be filled with discussions and case studies.

Program overview:

  • Highlights of transition from MDD to MDR
  • Strategic options in the transition phase
  • How to do a  gap assessment of your technical documentation, use of templates and checklists
  • How to do a gap assessment of your QMS, use of templates, checklists and management summaries.
  • How to do a gap assessment of clinical evaluation, use of templates and checklists.
  • Portfolio review
  • Impact assessment
  • High-level implementation planning
  • Case studies
  • Questions & Answers
  • Evaluation of the Course and Closing

Learning objectives:

  • Learn to perform various gap assessments at the start of MDR project
  • Learn to reflect on the portfolio
  • Learn to structure implementation project
  • Understand how to build and use assessment lists, tools, and templates

Who should attend?

RA manager, RA director, QA manager, QA director, Clinical Director, Marketing Manager, Sales Manager, international registration department

Gert W. Bos, PhD, Fraps
Stefan Menzl
Peter Reijntjes
Datum der Veröffentlichung: November 20, 2018
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