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In-Vitro Diagnostics


TÜV Rheinland

For the detection of disease, infection or other health conditions, in-vitro diagnostics are used both in professional medical settings and by consumers at home. The reliability and safety of these products is your company’s top priority as you strive to compete in the health care market. With our services and top-notch staff of specialists, you can meet compliance demands while boosting consumer confidence in your brand. Partnering with our experts gives you access to our state-of-the-art laboratories, know-how and unparalleled experience.

Our portfolio

Active Implantable Medical Devices (AIMD)
Active Implantable Medical Devices (AIMD)  

Conformity Assessments for Your Active Implants.

Active und Non-Active Medical Devices
Active and Non-Active Medical Devices 

Active and Non-Active Medical Devices.

CB Procedure
CB Scheme 

Safety testing and CB certification for electrical and electronic components and products.

EN ISO 13485 Certification
Certification According to EN ISO 13485 

Validating Your Quality Management System.

Green Product Mark
Green Product Mark 

One, single label indicating the overall environmental preferability of your product - direct, quick and efficient.

In-Vitro Diagnostic Devices (IVD)
In-vitro-Diagnostic (IVD)  

We Can Test and Certify Your Quality Management System and Products.

Japanese Pharmaceutical Affairs Law (PAL)
Japanese Pharmaceutical Affairs Law (PAL) 

Is Your Medical Equipment Certified in Japan?

Contact

Get in contact with us!

Get in contact with us!