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

eIFU Services

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 »

eIFU Services

Provide your electronic Instructions For Use over the internet in compliance with applicable regulations (eIFU) … 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, European Regulations and/or ISO9001/ISO13485 quality system standards. Furthermore, Qarad offers eIFU 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's 3rd IVD-Regulation Conference

Brussels
October 3-4, 2018

For the third year in a row, Qarad organized a two-day conference entirely focused on the European IVD Regulation 2017/746 !

Click here for more information!

Click here to see all upcoming events.

AACC

Chicago
July 31 - August 2, 2018

Click here to schedule a meeting with Dr. Dirk Stynen (President) or Chantal Huysmans (International Sales Manager) at AACC 2018!

Visit our booth #442!

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Qarad is hiring!

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

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