START YOUR APPLICATION PROCESS

Please complete and submit the form below to provide your initial information as enquiry to QMD Services. Please note, only fully completed forms can be processed.

Applications for conformity assessment activities acc. to Regulation (EU) 2017/746 on in vitro diagnostic medical devices and Regulation (EU) 2017/745 on medical devices are accepted in English language only.

    Is your quality management system (QMS) ISO 13485 certified?
    What type of service do you require
    (select all that apply):
    IVDR Product Category and number of devices
    (select all that apply):
    MDR Product Category and number of devices
    (select all that apply):
    Sterile Device(s)
    Method(s) of sterilisation
    Expected date when your Technical Documentation would be ready for conformity assessment.
    Role of applicant
    (select all that apply):
    Product / System description:
    Please input full and descriptive information including IVR, IVP, IVS, IVD and IVT codes, MDA/MDN codes, device classification

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    • TERMS AND CONDITIONS

    • TERMS AND CONDITIONS ADDENDUM