A requirement for testing medical devices varies by the device and the location of submission. In the United States, the Food and Drug Administration (FDA) is responsible for reviewing and regulating the medical device industry. In Europe, and other parts of the world, the International Standards Organization (ISO) sets the requirements. In some cases the standards do not agree, but work is being done at the committee level to increase the harmony among the different standards documents. In the U.S., AAMI represents U.S. interests in ISO. The latest versions of standards are available at www.aami.org . Another active standards organization that is working to create and refine standards on medical device testing is ASTM international, their web site is www.astm.org .
Medical Device Testing
Stent Testing
Heart Valve Testing
Latex Vessels
Silicone Vessels
Independent Laboratory
Testing Services
