IVD TRIALS – Your German partner for high-quality trials
With our expert team and numerous test systems, we perform the entire validation process for you at our own facilities.
Take advantage of our extensive know-how in analytical and clinical validation, compliant with the EU IVDR, WHO, TGA or Chinese NMPA.
Take advantage of our extensive know-how in analytical and clinical validation, compliant with the EU IVDR, WHO, TGA or Chinese NMPA.
For you, this means:
- Rest assured: You are working with professionals
- Highest quality at a reasonable price
- The best chances for an approval of your assay
Getting your ivd approved
Are you looking to validate your IVD products according to EU IVDR?
This is why our experts guarantee the best chances for an approval of your assay:
100% in-house expertise, no freelancers or subcontractors
direct access to more than 900,000 human biospecimens in stock as part of the German MEX Group
proven record from more than 250 successful clinical IVD trials at highest quality levels

Our services
Our study offerings include clinical and analytical performance evaluations for all major methods such as PCR, rapid tests and immunoassays (CLIA), including usability studies, e.g. laymen studies (self-testing), and near patient testing (PoC, Point-Of-Care).
Comply with all regulatory requirements such as European IVDR, Chinese NMPA, Australian TGA or WHO regulations.
What sets us apart
We understand the unique requirements of your project. This is why we will provide you with exceptional support and resources.
Unlike many other CROs, we offer a full service:
Unlike many other CROs, we offer a full service:
For you, this means:
- Daily prospective collections in own donation centers with hundreds of donors. Precise sourcing of samples for your study
- Large L2 and L3** lab facilities that allow us to work with specific risk group 3 pathogens such as SARS-CoV-2 or HIV
- Access to Europe’s largest commercial inventory of human biospecimens as part of the German MEX Group, as well as a worldwide samples network. This enables us to source for you a wide range of clinical samples, such as dengue or chikungunya samples from newly infected patients, all HIV subtypes, or progression samples from Lyme disease patients
- Study design, ethics approval, study performance, data analysis, and the final report, all included at the highest quality levels
- A quality management system that is accredited to ISO 9001 – all studies are performed in accordance with ISO 20916:2019 and ISO 14155; currently, we are working on obtaining ISO 17025 certification for our laboratories
How we conduct your study – together with you
FAQ
Frequently Asked Questions:
Do you have any further questions? We are happy to assist you via e-mail, phone or let’s have an online-meeting.

What our customers say:
„Thanks to the professional support of IVD TRIALS,
this comparative study was a great success.“ – finddx | Diagnosis for all