TueV NORD CERT GmbH

TÜV NORD CERT –

Your partner for conformity assessment and certification of medical devices and related services

Designations and accreditations

• Notified body (CE 0044) for medical devices in accordance with the Medical Devices Regulation EU 2017/745 for medical devices (MDR)
• Accredited certification body for EN ISO 9001
• Accredited certification body for EN ISO 13485
• Accredited certification body for EN 15224 (TÜV NORD Hellas)
• MDSAP Recognized Auditing Organization (TÜV NORD USA)

Medical Device services

• Conformity assessment procedure in accordance with the Medical Devices Regulation (EU) 2017/745 for active and non-active medical devices
• Certification of QM systems in accordance with EN ISO 9001, EN ISO 13485, EN 15224 and MDSAP

Project Management Medical Device International

• One Project Manager for the entire certification cycle
• Support for our clients from first quotation request to final certificate
• Steady communication
• Main contact in terms of commercial, organizational and certification topics
• Full Transparency for the status of your certification project