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.

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

USA
– FDA QSR/GMP 21 CFR 820
– MDR 21 CFR 803

CANADA
– Medical Device Regulations
– CMDCAS