Online Training

Requirements for a EU-MDR compliant QM-System

Important aspects to avoid pitfalls

Available Dates & Times

● 13. June 2024:     10:00-14:00 h CET
● 24. July 2024:         8:00-12:00 h CET
● 28. Aug 2024:      15:00-19:00 h CET     | US EST 09:00am-1:00 pm
● 27. Sept 2024:       8:00-12:00 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.-

Overview of covered topics

Purpose of the training

Participants will be enabled to understand,

Who should attend

Basic knowledge required

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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