Classification, Risk Assessment, Design Dossier, Clinical Evaluation, Performance Evaluations, Labeling, …Read more »
Device Notification, Incident Management, Liaison with Competent Authorities, …Read more »
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 »
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 translation services and 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.