Qarad

Qarad 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

Company’s Keywords:

consulting, regulatory affairs, in vitro diagnostics, ce marking, authorized representative, training, quality system implementation, online instructions for use, performance evaluation ivd, risk management, elabeling, iso13485, eifu, scientific validity reports