07.10 Consulting services for health organisations
Consulting services for health organisations
Qarad is a Belgium based company offering Expert Consultancy in EU and US regulations for In Vitro Diagnostics (IVD) and Medical Devices (MD). Apart from regulatory consultancy, our main services are the organization of Performance Evaluations for IVD and assistance in the implementation of Quality Management Systems according to ISO13485. Furthermore, we are the Authorized Representative for a high number of non-EU based manufacturers of IVD and MD. A strong belief that new technologies should make our customers life easier, linked to an in-depth knowledge of IVD and MD regulations, resulted in the development of our eIFU services. 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. Qarads eIFU services are offered based on a configurable standard platform or as a tailor-made solution, both familiar to the Notified Bodies.