Qarad, part of the QbD Group, is a Belgium-based company offering Expert Consultancy in EU regulations for In Vitro Diagnostics (IVD). 

We can help with your technical documentation, assist in how to obtain your CE mark or help you to understand the different regulations. Apart from the regulatory consultancy, our main services also include the implementation of Quality Management Systems according to ISO13485.

Since the foundation of Qarad in 2000, our services have grown rapidly. We organize Performance Studies in collaboration with well-renowned evaluation centres and blood banks. Moreover, we can also write your Clinical evidence documentation (such as Scientific Validity Reports, Clinical and Analytical Performance Evaluation Plans and Reports). 

Furthermore, we are the Authorized Representative (EC-REP) for a high number of non-EU based manufacturers of IVD and Medical Devices.

Last but not least: our in-depth knowledge of IVD and MD regulations combined with a strong belief that technology can make your life easier, resulted in 2008 in the development of our eIFU services. By offering a platform that complies to the regulations, you can distribute your Instructions For Use and other documents online. 
We differentiate ourselves in the eIFU area by offering a single supplier solution, developed by regulatory experts with a focus on compliance and risk management. Our solution is familiar to the Notified Bodies.

#IVD #RegulatoryAffairs #QualitySystems #CEmark #AuthorizedRepresentative #EC-REP #PerformanceStudies #ClinicalEvidence #ScientificValidityReports #SVR #E-labeling #eIFU #MedicalDevices

QbD IVD | Qarad

Pas 257 in Geel supports medical device compliance, scientific writing, and performance evaluations for health technology.

Pas 257

This department focuses on providing expert advice and solutions related to in vitro diagnostics across various domains including medical writing, clinical evidence, and regulatory affairs.

IVD Consulting

This department provides expert guidance and strategic advice to clients in various sectors.

Consulting Services

This department oversees the strategic direction and governance of the organization.

Executive Board

This department focuses on enhancing organizational performance through evaluation studies and quality management practices.

Performance and Quality

This department is responsible for the management and communication of scientific information and ensuring compliance with regulatory standards.

QbD IVD | Qarad

Org chart

Teams

IVD Consulting

Consulting Services

Executive Board

Performance and Quality

Scientific Affairs

Offices

QbD IVD | Qarad

Org chart

Teams

IVD Consulting

Consulting Services

Executive Board

Performance and Quality

Scientific Affairs

Offices

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