Working together, our regulatory consulting services partners empower you to maintain control of your pathway and have a clear understanding of your compliance risks. With practical interpretation, we help you understand how the diagnostic guidelines around the world apply to you.

Next to the development of regulatory strategies and compliance plans AMICONbio, together with its network of associates, provides hands-on support:

We provide full technical and medical writing support to manufacturers of Medical Device and In vitro Diagnostic devices to obtain CE-marking as per EU regulations of MDR (2017/745) and IVDR (2017/746) for entering European market.

Together, we bring your medical device to the global market.