Overview
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).
The SVR is a critical component of the IVDR in that it establishes the association of the analyte with the clinical condition or physiological state. Regulators expect manufacturers to demonstrate a thorough clinical evaluation of the IVD in the context of what is generally acknowledged as SOA. To establish that your IVD reflects the current best-practice, 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. Here, we discuss the critical role of the SVR in establishing SOA as it relates to the overall performance evaluation process.
Solution
The SVR is your chance to …
Download the rest of this white paper here.
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