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Testing and Assessment Services for In-Vitro Diagnostic Devices

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.

Unannounced audits

Unannounced audits

Commission Recommendation of 24th September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) was published on 24 September 2014 and entered into legal force on 25 September 2013 by publication in the Official Journal of the European Communities.

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New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf New MDR 1 MB Download
pdf Information according to the new European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) 290 KB Download

Our portfolio

Acoustics Testing and Measurement
Acoustics Testing and Measurement 

Audiological Testing and Vibration Measurement.

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

Active and Non-Active Medical Devices.

Electromagnetic Compatibility (EMC)
Electro­magnetic Compatibility (EMC) and Tele­communications (RED) 

Do Not Disturb and Do Not Be Disturbed.

EN ISO 13485 Certification
Certification According to EN ISO 13485 

Validating Your Quality Management System.

Energy Efficiency and Saving Energy
Energy Efficiency and Saving Energy 

Improved Climate Protection with Energy-Saving Products.

FCC Compliance Testing and Approvals
FCC Compliance Testing and Approvals 

We are accredited to provide FCC compliance testing and approval for entry into the US market.

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

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

Information Technology Products
IT Product Testing 

We test and certify your IT and telecommunication products.

LoRa Alliance Certification
LoRa Alliance Certification Program 

We test and certify your LoRaWAN devices according to the requirements and specifications of the LoRa Alliance.

Medical Devices: International Approval
International Approval for Medical Devices 

Your Gateway to New Markets.

RED Directive: Telecommunication Products
Telecommunication Products - Compliance with RED Directive  

Conformity Evaluation for Radio Installations and Telecommunications Products.

RoHS Compliance Testing
RoHS Compliance Testing 

The Electrical and Electronic Equipment Act.

Usability and Ergonomics
Usability and Ergonomics 

A Real Plus for Your Customers: Functionality and Ergonomics.

WEEE/RoHS Services
WEEE/RoHS Services  

Get Your Electronics Products Compliant with Waste Directives.

Wi-Fi Testing and Certification
Wi-Fi Testing and Certification 

We provide Wi-Fi testing and certification for wireless products sold around the world.

Zigbee Testing and Certification
Zigbee Testing and Certification 

We test and certify products for automated smart systems supported by Zigbee technology.

Contact

Get in contact with us!

Get in contact with us!

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