Medical engineering: Solutions for safety, quality, and compliance

Services for manufacturers, operators, and service providers

TÜV NORD supports manufacturers, operators, and other stakeholders in the medical engineering sector by offering comprehensive services that cover safety, quality, and compliance. With our many years of experience, we ensure the safe operation of medical devices and build trust, always complying with internationally recognized standards.

All services for medical engineering

A team of scientists is working together in a lab, reviewing data on a tablet

Quality, safety, and compliance in medical engineering

Medical technology – Safety for patients and users

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:

Safety and trust in your products
Compliance with laws and standards
Practical support for operators, manufacturers, and service providers

A summary of the services we offer

Discover our services related to medical devices, quality management, product safety, cybersecurity, and regulatory requirements.

Medical device ceritfication & MDR compliance

Quality management for medical devices

Testing and safety for medical technology

Cybersecurity und IT-Security in medical technology

Certification for primary packaging for medical products

A team is working together in a technology lab

Medical device ceritfication & MDR compliance

TÜV NORD provides conformity assessment services to medical device manufacturers in accordance with European requirements. As under the previous legislation, TÜV NORD CERT GmbH is one of the European Notified Bodies (Scope of desingation of TÜV NORD CERT in NANDO).

Medical Device Regulation (MDR)

Guide to changing your Notified Body

Quality management for medical devices

A robust and effective quality management system is the foundation for safe and compliant medical devices. We provide certification and audit services for companies in accordance with relevant standards and programs in the medical device sector.

ISO 13485 certification

Medical Single Audit Program (MDSAP)

DIN EN ISO 13485 certification according to KRINKO/BfArM

CT scans using modern x-ray technology in medical diagnostics

Testing and safety for medical technology

The technical safety of medical devices is an essential prerequisite for their reliable use. We support companies by conducting tests in the areas of electromagnetic compatibility (EMC) and radiation protection.

EMV & Medizintechnik

Medizinischer Strahlenschutz für Kliniken, Radiologie und Praxen

Cybersecurity und IT-Security in medical technology

The digitization of medical technology increases the demand for cybersecurity and information security. We help companies demonstrate compliance with these requirements through audit and certification services based on recognized standards.

ISO/IEC 27001 Zertifizierung

Zertifizierung nach IEC 62443

Blister packs and other forms of pharmaceutical packaging

Certification for primary packaging for medical products

We support companies by providing quality management system services for the manufacture of primary packaging in accordance with internationally recognized standards.

ISO 15378 Zertifizierung

Medical technology seminars

In addition to our testing, auditing, and certification services, we offer seminars on the latest topics in medical technology. Our seminars provide practical knowledge in relevant fields.

QM medical devices & helathcare

Two TÜV NORD employees discussing certification

The benefits of partnering with TÜV NORD

Comprehensive expertise in medical technology:
Our experts have decades of experience and expertise in medical technology. We support companies in meeting regulatory requirements and demonstrating recognized technical competence.
Internationally recognized services:
TÜV NORD stands for independent testing, certification, and assessment in accordance with recognized national and international standards.
Flexible and practical solutions:
Our services can be tailored to companies of various sizes, product types, and requirements in the medical technology sector.

Frequently asked questions about our services

TÜV NORD offers a wide range of services to support manufacturers, operators, and other stakeholders in the medical technology sector. These services include conformity assessments in accordance with the MDR; quality management certifications; testing in the areas of electromagnetic compatibility (EMC) and radiation protection; cybersecurity services; certifications for primary packaging; and training courses on relevant technical topics.

TÜV NORD has many years of experience in the field of medical technology and supports companies with independent testing, audits, and certifications.

Yes, TÜV NORD offers seminars and continuing education courses on various topics in medical technology. These training programs provide practical knowledge in relevant fields.