The IVDR has many companies scrambling and feeling a bit disorganized. The new regulations include multiple technical documents, as well as the Performance Evaluation Report (PER). But how do all of these pieces fit together? In this webinar, we discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report. Based on our experience with both the MDR and IVDR, we will discuss timelines, resources, and strategies to build a strong foundation to support your IVDR writing team.
Who's is this Webinar For?
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions.
|June 7, 2023||Watch at a Convenient Time||Recorded|
Takeaways from this session:
Understand how organization and clarity are critical for the success of your application
Learn tips and best practices for writing a PER and incorporating technical documents
Have your most-asked questions answered by regulatory writing experts