Training

MDR Suite #2: QMS | Beyond the obvious aspects we already know

March 02, 2021

Date: 2nd of March 2021

Time: 16:00h -18:00h CET 

Location: Virtual

Language: English

Costs: € 395,-

Package deal 12 (sessions): € 3750.-  *

* Team Members with Different Roles & 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, 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 very obvious in the MDR, yet very crucial that manufacturers account for them in the QMS for MDR readiness.

Learning Objectives:

  1. Most of the top-level QMS procedures will require updates
  2. The most significant QMS gaps are typically in PMS, Clinical/Performance Evaluation, Technical Files, and Design Control
  3. Obstacles are typically around clear identification of responsibility, resources, unknowns, linkages and practical execution
  4. 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: November 24, 2020
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