Key Takeaways:
- The foundational role of the SOA in the SVR
- The required components of the SOA such as the safety and performance objectives
- The importance of a robust systematic literature review (SLR) to support your SOA
Who Should Watch:
- Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the SOA section within the SVR.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
