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

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 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

Qarad EU IVD-R Conference

Qarad organizes a conference, completely dedicated to the new IVD-Regulation. We will give a general overview of the regulation and its impact.

The conference will take place on October 27th, 2016 in the Faculty Club in Leuven, Belgium.

Click here for more information

Click here to subscribe

pic_medica

Medica 2016, Düsseldorf

Interested in what Qarad can do for you?

We are participating at Medica 2016 from November 14 until November 17 .

Meet us in Hall 3, booth J74!!


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