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

Company details

Kouwe Hoek 18
2741 PX Waddinxveen
The Netherlands

Tel: +31(0)182 389777
Fax: +31(0)182 389778
info@macromedics.com