Online Training
Requirements for a EU-MDR compliant QM-System
Important aspects to avoid pitfalls
Available Dates & Times
● 27. Sept 2024 8:00-12:00 h CET
● 12. Dec 2024 14:00-18:00 h CET USA - 8:00-12:00 h EST
● 29. Jan 2025 09:00-13:00 h CET
● 26. Mar 2025 13:30-17:30 h CET USA - 7:30-11:30 h EST
● 28. Mai 2025 09:00-13:00 h CET
● 30. Jul 2025 13:30-17:30 h CET USA - 7:30-11:30 h EST
● 24. Sep 2025 09:00-13:00 h CET
● 26. Nov 2025 09:00-13:00 h CET
Description
A Quality Management System (QMS) compliant to the new Medical Device Regulation EU 2017/745 (EU MDR) is an important pillar for developing and placing medical devices on the European market. The change from the Medical Device Directive to the Medical Device Regulation requires distinct adaptations of the QMS to comply with the Regulation.
The standard (EN) ISO 13485 is well known in the world of medical devices. After all, it was already commonly the basis for the certification of medical devices in accordance with EC directives and other regulatory systems worldwide.
However, EU MDR has defined additional requirements for quality management that must be considered. This training will guide through the requirements of (EN) ISO 13485 and additional EU MDR requirements and what in particular needs to be taken into account.
Net price
€ 330.-
- Access to online training
- Presentation slides as handout
- Certificate of attendance
Overview of covered topics
- (EN) ISO 13485 content and requirements
- Relationship between EN ISO 13485 and EU MDR
- Additional requirements of EU MDR
Purpose of the training
Participants will be enabled to understand,
- the key points of an EU MDR compliant quality management system
- when a quality management system according to EU MDR is required
- the legal and normative bases and requirements
- what must be specified in addition to EN ISO 13485
Who should attend
- Manufacturer
- Regulatory Affairs Manager
- Quality Manager
- Personal, directly or indirectly involved in the Quality Management System
Basic knowledge required
- Basic knowledge in EU-MDR
- QMS Standards in general
Presenting expert
Dr. Susanna Kerschl
Senior Consultant
AKRA TEAM GmbH
Dr. Anna Spehl
Senior Consultant
AKRA TEAM GmbH
Norchéne BenMadhi
Consultant
AKRA TEAM GmbH
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