Regulatory Affairs

Our Regulatory Affairs activities are mainly focused on Europe, the US and Canada.

In addition we have experience with submissions in other regulatory jurisdictions worldwide.


Medical Device Directive (MDD)
Active Implantable Device Directive (AIMD)
In Vitro Diagnostic Directive (IVD)
EN ISO 13485:2003


FDA QSR/GMP 21 CFR 820
MDR 21 CFR 803


Medical Device Regulations
CMDCAS