MDR -Transition

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TRAINING

MDR Transition

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

Program 

Highlights of transition from MDD to MDR

Strategic options in the transition phase

How to doa gapassessment 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

Questions & Answers


Learning Objectives 

  • Gather the business impacts of the regulation.
  • Understand the regulatory impact of remediation, retire, and transition of your product portfolio (portfolio rationalization).
  • Transition timelines and strategy options.
  • How to prepare an implementation plan, including tools, planning, costs.
  • Learn to perform various gap assessments at the start of MDR project
  • Learn to reflect on a 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

  • Professionals preparing for the MDR

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

 

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