In this practical presentation, Dr. Sarah Chavez, presents a detailed outline of the State-of-the-Art search within the Performance […]
This session's topic: The Performance Evaluation Report (PER) With the implementation of IVDR requirements, IVD manufacturers have been […]
This session's topic: The Performance Evaluation Report (PER) With the implementation of IVDR requirements, IVD manufacturers have been […]
How to Establish the State-of-the-Art Within the Scientific Validity Report In this presentation, Criterion Edge’s Principal Medical Writer, […]
In this practical presentation, Dr. Sarah Chavez, will present a detailed outline of the IVDR State of the […]
Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and […]
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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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