[FREE WEBINAR] Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
Click here to watch the webinar In this “Critical Concepts” webinar, we discuss rules for device classification under each regulation, as well as the risk-based classification rules as described in […]
[FREE WEBINAR] Critical Concepts: The Role of Post Market Activities in Establishing Data Sufficiency
Click here to watch the webinar In this webinar, we review the conformity requirements for legacy devices under the MDR and established devices under the IVDR to help you harness […]
[FREE WEBINAR] CER Critical Concepts: Effectively Telling the Story of the CER – Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis
Click here to watch the webinar Key Takeaways How to effectively identify, present and analyze CER parameters Understand how clinical outcomes differentiate from S&P objectives Learn how these key foundational […]
