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 are accepted in English only.

QMD Services have applied to be designated as a Notified Body for Regulation (EU) 2017/745 on medical devices (MDR) and we are in the final steps of the notification process. We expect designation as early as mid May 2024, but delays are still possible. We will start our Notified Body activities immidiately following designation. 


    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