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!
THE ONLY ONE-STOP-SHOP FOR IVD-VALIDATION
NEW: SERVICES FOR SARS-CoV-2 DIAGNOSTICS!
PLAIN SAILING FOR YOUR IVDs
Diagnostic study service
The IVDR 2017/746 demands scientific evidence for the performance claims of your IVD product. We help you with all necessary steps.
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.
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.
Samples, studies, reports. Everything you need for your IVD medical device, all in one hand.
Diligent quality management, certified according to ISO 9001:2015 and ISO 13485:2016.
We react fast and professional and push our projects forward.
After 20 years in the diagnostic industry we are well familiar with all IVD-development and -certification processes.