LabCertify is your partner for regulatory approval
Supporting access to Europe for in vitro diagnostics from across the world
Our approach
We are Scandinavian contract research organisation (CRO) specialising in in vitro diagnostics (IVD) driven by a passion for excellence.
Our dedicated team is committed to supporting your clinical studies with expert guidance, helping you achieve regulatory success.
Support from start to finish
LabCertify has extensive experience with pre-market clinical performance studies, performance evaluations, and post-market performance follow-up activities. We can also support you in laying out a clear path for the development of your in vitro diagnostic products.
The MedTech gateway to Europe
Our office is conveniently located the south of Sweden, a MedTech hub with direct access to the rest of Europe.
“LabCertify guided me through every step of my regulatory journey, from generating essential clinical performance data to crafting a robust strategy for post-market surveillance activities.”
— LabCertify Client, IVD Manufacturer, China