Training

MDR Suite | QMS

October 18, 2022

Date: 18 October 2022

Time: 16:00h - 18:00h CEST

Location: Virtual

Language: English

Costs: € 395,-

Package deal: € 3750.- * for all 11 sessions

* Team Members with different roles and responsibilities? No problem. We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package.

Introduction

During the course new and changed key concepts and requirements of the QMS discussed and reviewed and comparisons to business processes are made. As we read the MDR carefully, we will learn that there are several processes that need to be addressed in the QMS. This training is also intended to cover some of the areas that are not obvious in the MDR, yet very crucial that manufacturers account for them in the QMS for MDR readiness.

Learning Objectives:

  • Most of the top-level QMS procedures will require updates
  • The most significant QMS gaps are typically in PMS, Clinical/Performance Evaluation, Technical Files, and Design Control
  • Obstacles are typically around clear identification of responsibility, resources, unknowns, linkages and practical execution
  • Develop strategies early in the project to avoid these obstacles

Who should attend?

Quality Assurance Managers, Internal auditors, anyone involved in the implementation and maintenance of a Quality Management System in the Medical Device Industry.

Trainer:

Peter Reijntjes
Post date: February 10, 2022
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