ISO 13485/MDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING – upon request
(To calculate the correct time zone, please feel free to use the button “Time zone converter” and use Berlin as a reference European Time)
The ISO13485/MDR QMS training will give the attendees an insight into the requirements of the European Union Medical Device Regulation (EU MDR) related to the quality management system as well as an overview of the international standard ISO13485: 2016. A major focus will be on what is new in the ISO 13485:2016 in comparison with the previous version and how EU MDR and ISO 13485:2016 relate to each other. This training gives you an opportunity to fully understand the applicable regulatory requirements as well as gives insight into the concepts introduced by the ISO 13485:2016 in terms of the Quality Management System.
• Opening Remarks
• QMS under the EU MDR
• Quality Management System
• Management Responsibility
• Resource Management
• Product Realization
• Measurement, analysis, and improvement
• Relations between MDR and ISO 13485:2016
• Q&A session
• Closing remarks
- Start 08:30 AM – End 05:30 PM. Attendees are recommended to login 15 min in advance.
In order to keep the training interactive, the exact content schedule cannot be provided.
Certification:Personal Certificate will be provided in PDF
Presentation:Presentation will be provided in PDF