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Certification and Auditing Services for In-Vitro Diagnostic Devices


In-Vitro Diagnostics

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

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

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

Active and Non-Active Medical Devices.

Approvals for Greater China
Approvals for Greater China 

Let us help you with product approvals for China, Taiwan, and Hong Kong.

CB Procedure
CB Scheme 

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

cTUVus Certification
cTUVus Certification from an Accredited NRTL 

A step ahead of the rest – with cTUVus certification for the North American market.

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.

ISO 14001 Certification
ISO 14001 Certification for the Environmental Management System 

Have your environmental management system certified by TÜV Rheinland in accordance with ISO 14001.

Medical Device (tested)
Tested Medical Device 

Market Your Products More Effectively with Voluntary Certification.

Contact

Get in contact with us!

Get in contact with us!