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Bureau Veritas Training – Meet our trainers (Vol. 5)

Jul 4 2023

Meet our medical device standards expert

Bureau Veritas is one of the world's leading training organizations in the field of management systems. We offer over 3,500 seminars in the areas of quality, environment, health and safety in more than 70 countries.

Our trainers undergo an extensive qualification program and have extensive market and industry knowledge.

In this article we would like to introduce our expert for trainings in quality management and risk management especially in the field of medical devices:

Mélodie Kahl

Mélodie Kahl is a partner of Bureau Veritas since 2017. On behalf of Bureau Veritas, Mélodie has provided trainings and conducted audits on several standards, including ISO 9001, ISO 19011, ISO 14021, ISO 13485, GMP (Good Manufacturing Practices) and the EU-MDR (EU Medical Device Regulation).

About Mélodie Kahl 

Mélodie holds a Master of Science in Quality Management, an Executive MBA, and a DAS in Sustainable Business delivered by the University of Saint Gallen. She has coupled her degrees with a proven track record for leading strategic projects and growing her companies through the delivery of exceptional service.

In addition, Mélodie founded her first company KAHLITY in 2013, a consultancy provider to Medical Devices, Diagnostics and Pharmaceutical industries, headquartered in Basel-City Switzerland. Mélodie has experience in managing people in a multicultural and interdisciplinary environment, and by utilizing her large network and many partnerships, her team at KAHLITY is able to provide the best value for customers; often exceeding their expectations. This experience and expertise she incorporates into her trainings as well.

With trainings provided by Mélodie, you will get the most personalized and flexible services.

About The EU MDR / ISO 13485 Training

EU-MDR

This course is designed for anyone who want to understand the implications of the European Medical Device Regulation (EU MDR) and want to review the requirements of ISO 13485:2016.

Furthermore the course targets Medical Devices Manufacturers, Distributors, Importers, or Service Providers. The audience could include Quality Assurance and Regulatory Affairs professionals, and professionals from other departments such as Manufacturing, or R&D.

Goals

  • Understand the impact of the European Medical Device Regulation: Grasping the regulatory changes of the new EU-MDR Review 2017/745
  • Understanding the essential requirements of ISO 13485:2016

Content

  • European Medical Device Regulation

    • Grasp regulatory challenges of the EU-MDR 2017/745
    • Learn from experience on critical processes, specifically on Risk Management according to ISO 14971:2019 and ISO 24971:2020
    • Learn the content of a Technical File
    • Understand the key role of the PRRC (Person Responsible for Regulatory Compliance)

  • ISO 13485:2016

    • Understand the key requirements of ISO 13485:2016
    • Successfully implement or maintain a QMS in compliance with ISO 13485
    • Remain simple and flexible to continuously improve the QMS
    • Be ready at any time for an audit or an inspection

General Information

  • The training will include exercises with practical examples to encourage participants to participate
  • The training is designed for a maximum of 10 participants
  • The content of the training will include a general overview of the key points of the EU MDR and ISO 13485:2016, so it will serve as an introductory course, a taste of what to expect in our training courses on European medical device requirements. A follow-up training can be organized to provide further details on one or more specific topics. 
  • Duration: 2x ½ Days
  • Language: 
    • Training will be held in English 

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