This course will guide you through IVDR implementation. Find out best practices to implement a compliant QMS and prepare a thorough Technical Documentation package to obtain CE mark for your in vitro diagnostic medical device.

This course is designed to increase your understanding of IVDR key requirements to place your in vitro diagnostic medical device on the market.

This course introduces you to the key requirements of the IVDR. IVDs will now be classified according to their risk using a new rule-based system. The majority of IVDs will be subjected to independent assessment of their conformity to the Regulation by a Notified Body and will require third-party certification for the first time.

Designed to guide you through IVDR requirements implementation to obtain and maintain the CE mark for in vitro diagnostic medical devices. Learn more about IVD classification rules and conformity assessment routes. Increase your knowledge on General Safety and Performance Requirements in product development, performance evaluation and clinical evidence.

This course will guide you through IVDR requirements implementation. Find out best practices to implement a compliant QMS and prepare a thorough Technical Documentation package to obtain CE mark for in vitro diagnostic medical devices.

This short course will focus on how the IVDR prioritizes safety, effectiveness, and the highest standards of public health within the EU.

Bring world-class quality standards to your business with our introduction to ISO 9001 quality management training course. 

Look for a more flexible way to learn? This course is also available on-demand