Current NEWS:

The corona virus SARS-CoV-2 is presenting the global diagnostics industry with a tough challenge. New tests for the detection of the virus need to be developed as soon as possible while satisfying the high performance standards of the IVD branch. Already, there is a considerable number of tests on the market. Their quality, however, is often questionable. Separating the wheat from the chaff will be a major task for the upcoming months.

This is where we would like to introduce our expertise! Contact us and profit from our validation services for a professional performance assessment of your assay!

NEW: SERVICES FOR SARS-CoV-2 DIAGNOSTICS!

PLAIN SAILING FOR YOUR IVDs

The IVDR 2017/746 has caused a veritable earthquake within the in-vitro diagnostic industry. The new requirements regarding verifiable clinical evidence, ethical coverage, and meticulous reporting put a strain especially on small- to medium-sized enterprises, and thereby on the European IVD market itself. Our goal is to help companies cope with this challenge in order to avoid the predicted dwindling of this essential industry in the EU.

Studies

The IVDR 2017/746 demands scientific evidence for the performance claims of your IVD product. We help you with all necessary steps.

Samples

Acquiring human or animal samples is often the rate-limiting step of IVD-development and -production. As the European leader in biomaterial procurement we would gladly help you out.

Ethics & legal

For the IVDR-compliant conduct of studies a transparent communication with the ethics committee and legal authorities is mandatory. We will take care of this for you.

Logistics

Professional transportation and appropriate storage of biosamples are essential for the success of IVD projects. Place your trust in our experience!

One-Stop-Service

Samples, studies, reports. Everything you need for your IVD medical device, all in one hand.

Quality

Diligent quality management, certified according to ISO 9001:2015 and ISO 13485:2016.

Speed

We react fast and professional and push our projects forward.

Experience

After 20 years in the diagnostic industry we are well familiar with all IVD-development and -certification processes.

Contact us