Скачать или смотреть Ep18 Defining Performance Requirements

Coagusense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients to help them maintain warfarin dosage within a therapeutic range. But in the latest version of their device, they actually got rid of some connectivity features to accommodate the needs of their older, less-tech-savvy self-testers. So they had to go back to the FDA with more bench data for re-approval.

Andy Rogers talked with Mike Acosta, EVP/Head of Compliance, Coagusense, and later recapped some of the lessons learned with Senior Electrical Engineer Jake Cowperthwaite. It’s an informative discussion about how to define performance requirements when you’re aiming for FDA approval.