Don’t miss our e-Learning on IVDR implementation strategies.
In a series of 9 sessions we will help you to understand how the new IVDR will affect your product.
Within this e-Learning you will learn what the new requirements for post-market surveillance (PMS) and vigilance are under the IVDR and what the new requirements on trend reporting and post-market performance follow-up (PMPF) include. In the bonus segment you will get more insights into reports required specifically for class C and D IVDs and the required update cycle for the PMS, vigilance and PMPF documents.
More topics to be covered in the upcoming sessions
- Implementation Strategies for IVDR – Timelines and Priorities – Work Packages
- How REACH affects Medical Devices and IVDs
- Classification under IVDR
- Economic operators and regulatory functions under IVDR
- Performance evaluation and clinical evidence under the IVDR
- Update of the technical documentation meeting IVDR requirements
- EUDAMED and UDI under IVDR
After confirmation of your registration by knoell Germany GmbH, you will receive a link and an access code. From the time you receive the access code, the link to the e-Learning video is valid for 56 days. The video can only be accessed five times during this period.