What we do

We offer a wide range of services within the fields of Regulatoy Affairs (MDR/FDA), Quality Management, Information Security and Human Resources. We also offer Project Management and support you with implementing  your ERP, ISMS or Quality Management System.

 

Our Consultants have years of experience and broad knowlegde within our services.

Regulatory Affairs

We can offer assistance with your regulatory compliance in several regions throughout the world.

EU PRRC

CENIT can represent your company for this required position in order to maintain compliance to the EU MDR/IVDR.

US FDA Agent

We can serve as the US agent for medical device manufacturers who do not have a presence in the US.

Quality Management

CENIT can help organizations meet customer, market and regulatory requirements.

Information security

We can help implement your information security management system (ISMS). Towards your path to ISO 27001 certification.

Human Resources

We offer a wide range of HR Services. We can act as your HR Department or we can advice in HR related issues on a case to case basis.

Contact us:

If you would like to know more about our services or talk with one of our experts about your challenges, please contact us via the form and we will get back to you soon.