CENIT Consulting provide services within the area of Regulatory Affairs and Quality Management.
With offices in Norway and USA, we can assist with device approval submissions and can serve as your contact with EU Notified Bodies and relevant Regulatory Authorities both in the EU and US.
We can also serve as your Person Responsible for Regulatory Compliance (PRRC).
Our Regulatory Services:
· Regulatory Strategy based on Intended Use and Commercial Markets
· Gap Analysis of current systems to regulatory requirements
· Classification Assessment – EU MDR/IVDR and US FDA
· Risk Management – ISO 14971
· Design History File and Technical Documentation preparation
We also offer Project Management and support you with implementing your ERP or Quality Management System.