[Ask the Expert] Performance Evaluation Report
Virtual Q&AThis 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 […]
This session's topic: The Performance Evaluation Report (PER) With the implementation of IVDR requirements, IVD manufacturers have been […]
This session's topic: Safety and Performance Objectives and Acceptance Criteria for IVDR Do you have questions about how to […]
How to Establish the State-of-the-Art Within the Scientific Validity Report In this presentation, Criterion Edge’s Principal Medical Writer, […]
IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation In this webinar, we discuss the importance of […]
Safety & Performance Objectives and Acceptance Criteria How do I define acceptance criteria and how do I define […]
The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance […]
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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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