Cluster meets: Essential MDR-Requirements – Overview and Experience Exchange

13:00 till 14:00 o'clock
Kalendereintrag speichern
Online
Join us to explore the key aspects of MDR compliance and learn how to address these strategically during the early stages of product development.

 

The EU Medical Device Regulation (MDR) presents significant challenges for MedTech startups. Making the right decisions early on is crucial for a smooth product certification process and long-term market success. This webinar is designed to help startups gain a clear understanding of the MDR's foundational requirements and how to apply them effectively. In addition, a MedTech company from our capital region will share their hands-on experience on their recent MDR certification journey.

Target group: Medical device startups

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Agenda:

Part 1: MDR Overview Presentation by Claudia Tessenow, Senior Consultant Regulatory & Clinical Affairs, CEED @ Charité Healthcare Services GmbH

  • Definition and Classification of Medical Devices:
    • What qualifies as a medical device?
    • How is the product class determined, and what are the implications for the certification process?
  • Manufacturer Requirements:
    • Overview of regulatory obligations for manufacturers.
  • Quality Management System (QMS):
    • Why a QMS is essential and how to establish one effectively.


Part 2: Company view: Experience of recent MDR certification journey by Dr. Juliane Dinter, Quality and Regulatory Affairs Manager at Magnosco GmbH

  • The MDR certification journey: challenges and solutions.
  • Building a functional Quality Management System (QMS).
  • Practical tips to avoid pitfalls and save time.


Part 3: Q&A

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Please note:
Participation in this online event is free of charge. Please register under the above link. You will receive a dial-in link one day prior to the event.

In case of any questions please contact Flavia Kruse under Flavia.Kruse@berlin-partner.de.

 

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