WARMING MATTRESS

Our Quality Management System is compliant to ISO13485:2016, as well as Medical Device Single Audit Program (MDSAP) requirements for Australian TGA, Health Canada, USA FDA and Japanese MHLW / PMDA and also is designed to meet the requirements of FDA 21CFR part 820. The devices sold in the EU all conform to the requirements of the European Medical Devices Directive 93/42/EEC (as amended) and are RoHS 2 Compliant. Additionally some products meet the requirements of the FDA, Health Canada and other regulatory authorities around the world.