Quality Assurance

Jarvik Heart's commitment to quality may best be summarized in the policy statement that hangs over our quality control department: "Jarvik Heart, Inc. will develop and provide products and services that meet or exceed our customers' expectations for safety and effectiveness in use."

Everyday, JHI employees work under a sign bearing these words. Tacked next to the sign are letters and photographs from Jarvik 2000 patients on the mend, a constant reminder of why we do what we do.

But quality control is more than an abstract concept. To deliver a medical device that "exceeds our customers' expectations for safety and effectiveness," a company must have robust procedures in place for the manufacture and testing of its products. JHI maintains ISO 13485:2003 certification from the International Organization for Standardization (ISO) to ensure that all of its pumps and components meet rigorous quality standards applied by top companies throughout the world.