Qarad - Your regulatory gateway to Europe
for IVD and MD

Consultancy in regulatory affairs and quality systems for IVD and MD

Services for IVD and Medical Devices

E-Labeling and

CE marking

Classification, Risk Assessment, Design Dossier, Clinical Evaluation, Performance Evaluations, Labeling, …Read more »

Authorized representative

Device Notification, Incident Management, Liaison with Competent Authorities, …Read more »

Quality systems

According to MD and IVD Directives, ISO13485, ISO9001, ISO17025, ISO15189, …Read more »


Compliant E-Labeling Solution for IVD and MD, Translations of Instructions for Use, …Read more »

Meeting your regulatory objectives in the EU and worldwide

As a Medical Device or IVD manufacturer, you will want an efficient introduction of your products into the unified European market. Qarad can assist you with the necessary regulatory support and other services. These include advice and training on the various requirements for the CE marking of your devices and for the implementation of a quality system according to European Directives and/or ISO9001/ISO13485 quality system standards. Furthermore, Qarad offers translation services and e-labeling solutions.

You do not have a registered place of business in a European member state? Qarad can act as your authorized representative (EC REP). This allows you to keep compliance separate from commercial interests and to remain independent from your distributors in regulatory issues.

Qarad can also help you with the implementation of a quality system meeting the FDA's Quality System Regulation (21CFR820) and Canadian standards. We prepare product submissions for different geographic areas and will seek assistance of appropriate partners, if appropriate.

Recent News

Dirk Stynen will participate at Informa:

Labelling Compliance and UDI Implementation for Medical Devices and IVDs

Tuesday 28th - Thursday 30th of October 2014

>> Click here to schedule an appointment <<
>> Click to learn more <<

Authorised Representative Services
Authorised Representative Services
Check out our new Authorised Representative Services Flyer!
E-Labeling Services
E-Labeling Services
Check out our new E-Labeling Services Flyer!