[FREE WHITE PAPER] State of the Art: Establishing a Solid Foundation For Your PERs to Encourage IVDR Readiness
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 …
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
3rd Party Cookies
This website uses Google Tag Manager and Pardot's tracking features to collect information such as the number of visitors to the site, and the most popular pages. Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!