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 …
Download the rest of this white paper here.
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Tags: In Vitro Diagnostics, IVDR, performance evaluation report, safety and clinical performance, state of the art
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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