Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance In this presentation we discuss […]
This session's topic: Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance Are you […]
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 […]
Clinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER - Focus on S&P Objectives, Acceptance […]
Ask the Expert: Clinical Evaluation Report Template and Critical Concepts This session is presented from the point of […]
With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems […]
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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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