Medical Device Regulation (MDR) – Implementing Requirements in the Quality Management System
The European Medical Device Regulation (MDR, 2017/745) has been in effect since 2017. Every manufacturer of medical devices classified from Class I to III is legally required to establish, document, apply, maintain, update, and continuously improve a Quality Management System (QMS). MDR requirements also apply to other economic operators such as EU authorized representatives, distributors, and importers. These requirements go far beyond the scope of common standards like ISO 13485:2016 or ISO 9001:2015.
This seminar provides you with the regulatory fundamentals and the necessary content of MDR for QMS. We highlight the need for updates to existing systems and equip you with the essential knowledge to align your QMS with MDR. In this one-day seminar, you’ll gain a compact overview of how to establish the new and required MDR elements within your quality management system.
- Regulatory foundations in the Medical Device Regulation (MDR)
- Impact on economic operators in Europe
- Who is required to have a Quality Management System?
- Required content of a QMS according to MDR
- Impact on QMS compared to ISO 13485:2016
- Necessary updates and changes
- Scope, liability aspects, Person Responsible for Regulatory Compliance (PRRC), registration of products and economic operators, labeling and instructions for use, advertising materials, indications, implant card
- SSCP (Summary of Safety and Clinical Performance), PMS plan and report/PSUR, obligations of economic operators in PMS, Post-Market Surveillance, Unique Device Identifier (UDI), EUDAMED
- Practical implementation of MDR in QMS
Sound knowledge of MDR and ISO 13485:2016
English
Certificate of participation from TÜV SÜD Akademie
This training is being operated by TÜV SÜD Akademie GmbH in Germany. The General Terms and Conditions as well as the Privacy Notice of TÜV SÜD Akademie GmbH apply. In case of any questions, do not hesitate to contact us.