Under Construction
QRcompliance is working on the establishment of online training modules related to Quality Assurance and Regulatory Affairs for professionals working in the field of (IVD) Medical Devices. Examples of topics under development are:
Quality Awareness
What is quality and why is it important.
ISO 13485:2016
“Medical devices - Quality management systems"
The structure and requirements of the standard explained.
European Regulation 2017/746 (IVDR)
Technical documentation compliant to the IVDR
How to establish the required technical documentation for the CE-marking of a In Vitro Diagnostic Medical Device.
Please leave a message if you want to be informed about the launch of the Online Training Services.