ISO 13485/IVDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING – upon request

The Standard ISO 13485:2016 on Medical devices – Quality management systems – Requirements for regulatory purposes got updated in 2016. The ISO 13485:2016 / EU IVDR QMS training will give the attendees insight into the requirements of the European Union In Vitro Diagnostic Medical Device Regulation (“IVDR”, (EU) 2017/746) related to the quality management system as well as an overview of the international standard
ISO 13485:2016. A major focus will be on what is new in both, the IVDR as well as the ISO 13485:2016, and how (EU) IVDR and ISO 13485:2016 relate & complement each other. Through this training, you will gain an understanding of applicable regulatory requirements (IVDR) and get insight on the concepts established in the ISO 13485:2016 for Quality Management Systems of players in the IVD medical device field, all while gaining proof of competence from subject matter experts.

• Opening remarks
• ISO 13485:2016 QMS requirements for regulatory purpose
o New elements
o Management Responsibility
o Resource Management
o Product Realization
o Measurement, analysis, and improvement
• QMS according to IVDR, (EU) 2017/746
o New compared to the IVDD, 98/79/EC
o Economic Operators
o Technical Documentation, incl. Performance Evaluation
o Conformity Assessment
o PMS, and Vigilance
• Relations between ISO 13485:2016 and IVDR
• 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.