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 »
Provide your electronic Instructions For Use over the internet in compliance with applicable regulations (eIFU) … Read more >>
As a IVD or Medical Device 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, European Regulations and/or ISO9001/ISO13485 quality system standards. Furthermore, Qarad offers eIFU 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.
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