[Ask the Expert] Common Notified Body Review Findings
Virtual Q&AThis session's topic: Tips For How to Avoid Common Notified Body Review Findings Criterion Edge is often approached […]
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 […]
Bridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs What do I do if there […]
Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process In the first part of […]
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 […]
Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency In this webinar, we will review […]
Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies In September 2022, […]
In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic, […]
Join us on Wednesday, April 5th, 2023 at 11 AM PST, as our experts discuss best practices to guide the development of common forms of plain language communication intended for the patient and their families and/or caregivers.
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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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