Devices which are sold in the European Union must meet the essential requirements of the Medical Device Directive 93/42/EEC before they can be CE marked. All MacroMedics Patient Positioning Devices are CE marked.
FDA is the U.S. Food and Drug Administration, an agency of the United States Department of Health and Human services. The FDA legislation protects the public health through the regulation and supervision of food and medical products. Please contact us for availability for the US-market. A large selection of our products is 510(k) cleared or listed.
ISO is the International Organization for Standardization. ISO facilitates and supports international trade by developing standards. These standards are recognized and respected worldwide. The MacroMedics Quality System is ISO13485:2012 certified by KIWA.
Download ISO cerificate