European Medical Device Consulting Services

Emergo Group helps medical device and IVD manufacturers obtain regulatory approval to sell their medical devices in Europe. Our European medical device regulatory consultants can assist you with many quality assurance, regulatory compliance and other issues as shown below.

Authorized Representative (EC REP) for Medical Device & IVD Companies

We act as the official EC REP for 400+ medical device & IVD companies worldwide.

CE Mark Consulting for Europe - Medical Devices and IVD

Obtaining regulatory approval to sell medical devices and IVDs in Europe is an Emergo specialty.

CE Technical File Preparation

We have prepared CE Technical Files and Design Dossiers for a wide variety of medical devices and IVDs.

Training on the Medical Devices Directives (MDD) and CE Marking

We provide on-site training for employees that need to be educated on Europe's medical device regulations.

ISO 13485 Quality Management System (QMS) Implementation Consulting

Our consulting team can lead you through every step of implementing ISO 13485:2003 at your facility.

ISO 13485 Auditing

Let us ensure that you (and key suppliers) maintain compliance with ISO 13485 and applicable European Directives.

European Medical Distributor Search

Our specialists can find distributors in any European country, including Germany, France, Italy and the UK.

ISO 14971 Risk Management Consulting

We have integrated ISO 14971:2007 into many ISO and US FDA QSR quality management systems.

Packaging Waste Directive Compliance & Green Dot Consulting

We help companies manage compliance with the European Packaging Waste Directive (94/62/EC).