IVD Deep Dive Series Part 1
Webinar , United StatesSafety & Performance Objectives and Acceptance Criteria How do I define acceptance criteria and how do I define […]
Safety & Performance Objectives and Acceptance Criteria How do I define acceptance criteria and how do I define […]
Clinical Data for IVD: What is it and How Do I Find It? Do you have questions about […]
Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report In Part 1 of our IVD Deep […]
In this practical presentation, Dr. Sarah Chavez, will present a detailed outline of the IVDR State of the […]
This session's topic: Tips For How to Avoid Common Notified Body Review Findings Criterion Edge is often approached […]
Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and […]
Scoping Your MDR and IVDR Writing Projects - The Forgotten Step In most of our webinars, we’ve focused […]
The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success […]
Ask the Expert: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process Regulatory Affairs is […]
Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies In September 2022, […]
New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference The In Vitro Diagnostics Regulation […]
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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