Whatever your unique challenge, we've probably been there before.
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.
We provide support with getting listed in the technical aid index and extensive CE-certification maintenance services, in addition to introducing quality management systems.
Profit from our knowledge.
According to the council directive 93/42/EEC concerning medical devices for non-European manufactures an authorized representative is mandatory.
EUROM - your authorised representative.
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.
Consulting, development, coordination.
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