Medical devices (MD)

The manufacturing, marketing, and advertising of medical devices (MD) are subject to very strict EU and local laws and regulations. It is crucial that every document related to medical devices is translated with accuracy, precision, and professionalism. This not only ensures compliance with legal and regulatory requirements but also plays a vital role in guaranteeing the safe use of these devices.

Medical devices must undergo a specialized authorization process prior to release. Following a compliance assessment, it is determined whether the device meets the relevant standards; if so, it receives the CE marking. Given the complexity of this process, our translation agency provides expert translations for all types of medical devices—including ordinary (MDD), active implantable (AIMD), and in vitro diagnostic (IVD) devices—throughout every phase of the authorization procedure.

Translation of documents related to medical devices:

• • • Documents related to compliance processes (e.g., production plan certification, certificate of conformity, type examination certification)
    • Clinical assessment(s)
    • Label text
    • User guide
    • Technical documentation (e.g. medical device description, user guide, risk management documentation, examinations performed, tests’ results, EC declaration of conformity)

Request a free quotation regarding translations of medical device documentations here