Unihelp
Consultants with expertise in certifications for medical devices for businesses and organizations in accordance with the increased requirements of the EU regulations. SERVICES • Quality Management System ISO 9001:2015 • Ministerial Decision 1348 • Quality Management System for Medical Devices ISO 13485:2016 • Quality of Health Services ΕΝ 15224 • MDR & IVDR Regulation • GreMDIS Registration • CE Marking • Environmental Management System ISO 14001:2015 • EUDAMED Registration
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