Analytical Performance Report vs. Clinical Performance Report: What Each Demonstrates Under IVDR
Analytical Performance Report (APR): Can the device reliably detect or measure the analyte? Clinical Performance Report (CPR): Do the device results meaningfully correlate with the intended clinical condition or physiological/pathological […]
[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 […]
