MD + IVD Regulatory Services & Competitive Intelligence
CND and EMDN Coding
We help companies to determine the proper EMDN code for each medical or IVD device on the European Market, with zero error and no waste of time. The service of CND-EMDN coding can be provided both offline (the company sends us the list of his products and, within few days, receives the corresponding EMDN codes) and online (the company queries the MeDGloX Database) through a yearly subscription.
NB – Since the EMDN codes and the updated Italian CND codes are the same, these codes can be used for both the registration in EUDAMED and the registration in the Italian Ministry of Health Database.
|Are you a manufacturer and have products registered in Italy? You can request a free check of the correctness of the CND classes that appear related to your products in the Italian Ministry of Health Database, by writing to firstname.lastname@example.org and specifying “free check CND” in the subject of the message.|
Registration of products in Italy and in Eudamed
We register medical devices in Italy and in EUDAMED, on behalf of companies.
NB – As for the provision of the service of registration in the Italian Ministry of Health Database, MeDGloX has signed an exclusive agreement with Confindustria Dispositivi Medici Servizi.
CE Mark, UKCA Mark, FDA Approval, Latin America certifications
We support companies to prepare the technical dossiers for getting the CE Mark, the UKCA Mark, the FDA Approval, and Latin America certifications.
MDR and IVDR compliance
We do consultancy to companies about MDR and IVDR. This service of consultancy can be provided remotely, by phone and email.
We support companies to set their own ISO 13485 quality management models. The service can can be provided remotely, by phone and email.
Online Access to our Database on Medical Devices and Market analyses
We offers to both companies and buyers business intelligence services based on the information included in our Database. These service can be provided both offline (the customer gives us the indication for the market study of interest and MeDGloX does it) and online (the customer by itself queries the MeDGloX Database. See the video-tutorial here below). MeDGloX Database will be available for online research on increasingly numerous markets, through a yearly subscription. Are you a subscriber user? To query the Database, click on the Medical Devices Search button in the Menu banner and login. A video-tutorial is on the right.
NB – MeDGloX is partner of IQVIA Italia for the provision of business intelligence services.
For more information about our services, or to ask for a price quotation, please contact us at email@example.com.
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