We specialize in registration and licensing but understand that each submission is unique. Our expertise is knowing what is right for each client and employ optimized methods. From CE-documentation to operating instructions to risk analysis, we have the solution to successfully coordinate your product’s application.
Enter the european market with EUROM
> Registering your devices with the Authorities to acquire market access
> Being your primary contact for all EU competent authorities.
> Maintaining a current Technical File for European Competent authorities inspection.
> Giving you authorization to use our contact information on your device label, packaging, instruction manual, etc.
> Mediating your contact with the national competent authorities
> Providing incident reporting to competent authorities, in collaboration with you and your distributors.
> Protecting your documentation confidentiality.
> Representing you at the European Commission for consultation, in instances withdrawal by member state(s).
> Maintaining critical data reports of data attained during clinical evaluations.
> Receiving and addressing serious device incident notifications from competent authorities.