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FOGOOL adheres to the highest standards for the manufacture of medical devices. Our quality assurance system is certified according to the ISO 9001:2000, ISO 13485:2003, MDD 93/42 standards, and complies with the United States Quality Systems Regulations Food and Drug Administration, RoHs standards. All our medical systems comply with the requirements of the EU Medical Devices Directive. Individual products are certified and/or cleared in the countries (for example, in the United States by the FDA) where they are used.
ISO 9001:2008 - Design, Manufacture and Inspection of Medical equipment Devices. Certification by TüV Rheinland.
ISO 13485:2003 - Design, Manufacture and Inspection of Medical equipment. Certification by TüV Rheinland.
EC-Certificate - Product Category: Medical equipment, MDD 93/42/EEC. Certification by TüV Rheinland.
ROHS Declaration of Compliance.
Quality Systems Regulations - Design Controls and GMP as required by the US FDA 510(K).