Company details
Suite 206
MD 21043 Ellicott City
United States
Call: +1 410 203 1248
a.palin@macromedics.com
Quality
MacroMedics has implemented a full Quality Management System and strives towards achieving quality in all of its activities. Key information on MacroMedics’ quality system and regulatory clearances can be found below.
CE marking
All MacroMedics Patient Positioning Devices are CE marked.
FDA
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.
A large selection of our products are 510(k) cleared. Please contact us for availability in the US-market.
ISO 13485
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 Management System is certified by KIWA. Download ISO certificate
