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Selumis® adheres to the highest standards for the manufacture of medical devices. Our quality assurance system is certified according to the ISO 9001, ISO 13485, 93/42EEC Annex II standards. All our medical systems comply with the requirements of the EU Medical Devices Directive. Certificates ISO 9001:2000 - Design, Manufacture and Inspection of Medical Laser and Radio Frequency Devices. Certification by TÜV RHEINLAND CORPORATE. ISO 13485:2003 - Design, Manufacture and Inspection of Medical Laser and Radio Frequency Devices. Certification by TÜV RHINELAND CORPORATE. EC-Certificate - The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC. Certification by TÜV RHEINLAND CORPORATE. |
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