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


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 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

We are looking for new colleagues !

We are looking for:

If you fit one of the profiles, don't hesitate to contact us.

Regulations regarding LDTs

FDA has backed away from their proposal to directly regulate Lab Developed Tests. However, they intend to bring forward further proposals soon due to their continued concerns over manufacturers offering RUO kits to labs and then supporting the lab to validate its “LDT” for clinical use.

Click here for more information

New European Data Protection Legislations

What are the implications for the industry?

Read more on our news page.
E-Labeling Flyer
E-Labeling Flyer
Download our new E-Labeling flyer and learn about the possibilities!