In order to market a device in Europe, you must comply with the European Directives for medical devices and affix the CE mark

.

The steps your company will need to follow are briefly illustrated below:

The most important elements of CE marking include:

RISK ANALYSIS

Your company must comply with ISO 14971, as well as, set in place a risk management system as part of your quality system.

Our team can help you in implementing a risk management system and integrate it into your quality system.

TECHNICAL FILE/DESIGN DOSSIER

The technical file is a comprehensive collection of information and documents that details everything about your medical device.

We can assist you in assembling a technical file (or design dossier) for your device.

CLINICAL EVALUATION

Device safety and performance claims must be based upon clinical data.

Push-Med can help you evaluate whether clinical data is necessary and develop the appropriate clinical trials in order to support your product claims.