TÜV NORD supports manufacturers and operators of medical devices with comprehensive testing and certification services. With our many years of experience, we create safety and trust in the operation of medical equipment, always in compliance with standards and internationally recognized.
All services for medical engineering
The role of technology in modern medicine is steadily growing. Whether in diagnostics or treatment – medical devices must meet the highest standards of quality and safety.
At the same time, legal requirements and standards are continuously evolving. For manufacturers and operators, this means dealing with complex regulations that demand absolute expertise.
TÜV NORD helps you meet these challenges.
Our testing and certification services are internationally recognized and provide you with:
We are also approved by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) for both active and non-active medical devices (Notified Body, identification number 0044).
Audits and certifications according to MDR, MDSAP, and ISO 13485. Support with regulatory requirements such as Krinko/BfArM.
Ensuring the electromagnetic compatibility (EMC) of your devices – essential for patient safety.
We support clinics, radiology departments, and medical practices with acceptance tests, recurring inspections, and quality assurance for X-ray equipment.
Protection of sensitive patient data through ISO/IEC 27001 and IEC 62443 certifications. IT security as an integral part of medical technology.
We certify primary packaging for pharmaceuticals in accordance with ISO 15378.
