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

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 »

(E)-labeling

E-Labeling Solution for IVD and MD completely compliant with EU and FDA regulations … 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 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

AACC 2017, San Diego

Learn all about the new IVD-Regulation at AACC 2017!!


Meet Qarad's experts July 31st until August 3rd in San Diego!
Dr. Maurizio Suppo, Co-owner of Qarad, and Ms. Chantal Huysmans, will be pleased to welcome you at our booth #1711!

Contact us to schedule a meeting!


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Qarad is hiring!

We are looking for a Technical writer and a Consultant specialized in Medical Devices. Click here for more information

Publication of the IVD-R and MD-R and its impact on eIFU

Qarad is glad to inform you that the new European Regulations for Medical Devices and IVDs  have been published in the European Official Journal on May 5, 2017.

More information

E-Labeling Flyer
E-Labeling Flyer
Download our new E-Labeling flyer and learn about the possibilities!