Public Training: MDR Transition

October 07, 2019

Date: 7th of October 2019

Location: The Netherlands, Amsterdam area

Language: English

Costs: Regular € 875.-

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.

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

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

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

Questions & Answers

Who should attend this course?

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

Trainer:

Peter Reijntjes
Post date: May 03, 2019
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