In this practical presentation, Dr. Sarah Chavez, presents a detailed outline of the State-of-the-Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example, the SLR approach, data screening, and data presentation will be addressed.
You will learn:
- The importance of the SOA SLR for providing background and general information
- How to establish acceptance criteria with data
- How to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process
Who should watch the recording?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission. Also, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend.
Watch the recording!
Building a Solid Foundation for your PER to Support IVDR Readiness
Watch our recent webinar where we present an overview of the State of the Art section. Namely, we explain how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER). In addition, a complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed establish your IVD as “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.
You will learn:
- The importance of planning and preparation before you even begin to write the SOA
- The complete outline of the SOA literature review and assessment process to understand “documentation” needs and what the Notified Body may be expecting to see as part of the Scientific Validity Report (SVR)
- The potential impact of incorrect/incomplete documents or processes
To watch the free webinar recording, State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness, click here.