Regulatory Affairs - Medical Devices

CENIT Consulting knows that navigating the medical device regulatory framework can be difficult, time consuming and costly. Our consultants have the knowledge and experience to guide your team through the requirements and onto regulatory compliance.

Medical Device 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

Submissions, Notified Bodies and Regulatory Authorities

The Consultants at CENIT Consulting 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 are able to serve as your Person Responsible for Regulatory Compliance (PRRC).

Global Regulatory Community

Our consulting team and our network of Regulatory Affairs Professionals have in-depth knowledge of regulations from around the world. We will work to ensure that your organization and device meet the regulatory requirements in the regions you wish to enter into.

Contact us to find out more about Regulatory Affairs