The Sapphire Infusion Pump by Eitan Medical Ltd. has undergone rigorous testing to verify its accuracy and reliability under various conditions. These tests ensure that the pump meets the high standards required by the FDA, providing dependable performance for patients and healthcare professionals. This bulletin summarizes the key findings and highlights how the pump meets these stringent requirements. Eitan Medical has analyzed the conditions that might affect the system accuracy (direct or indirect interaction with the pump) after considering the pump requirements, with literature search and regulatory guidance’s. The Sapphire Infusion Pump is a state-of-the-art medical device engineered for high accuracy and reliability in medication delivery. This bulletin outlines selected elements1 of the comprehensive testing conducted to verify the pump's accuracy across different scenarios, ensuring it meets FDA guidance’s and expectations and provides reliable performance in clinical settings.
