This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it fits into the In Vitro Diagnostic Regulation (IVDR).
Manufacturers are expected to demonstrate a thorough clinical evaluation of the IVD in the context of what is generally acknowledged to reflect the most current best-practice science. To establish that your IVD is SOA, you must be able to show how it fits into the entire scientific landscape and explain the circumstances and diagnostic scenarios by which the IVD can be considered SOA.
Knowing what the Notified Body expects to see will help you avoid …
[Ask the Expert] Safety and Performance Objectives and Acceptance Criteria for the PER
Join us for a LIVE Q&A session on January 26, 2022, at 11AM PST / 2PM EST with President Laurie Mitchell and Dr. Sarah Chavez. They will be answering questions regarding best methods and practices of identifying safety and performance measures and acceptance criteria for the performance evaluation report.
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