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 500+ 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.
Technical File and Design Dossier Preparation
We have prepared CE Technical Files and Design Dossiers for a wide variety of medical devices and IVDs.
Clinical Evaluation Report Consulting for Medical Devices
Let Emergo Group evaluate the clinical data for your medical device to ensure compliance with 2007/47/EC.
Clinical Trial Management in Europe for Medical Devices
Emergo Group's UK experienced clinical team can assist you with management of clinical trials in the EU.
Medical Device Reimbursement for Europe
Emergo Group's UK office can fully assist you with reimbursement issues in numerous countries within the EU.
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.
Online e-Labeling Service for IVD Products
We provide an online tool that can be used by IVD companies to replace paper versions of their Instructions for Use with an online version in compliance with MEDDEV 2.14/3 REV 1.
Packaging Waste Directive Compliance & Green Dot Consulting
We help companies manage compliance with the European Packaging Waste Directive (94/62/EC).
Qualified Person for Medicinal Products
Emergo Group's UK office can assist in ensuring that production and testing of medicinal products have been conducted to EU GMP and relevant requirements.
