Medical Devices
Medical Devices
Our team provides you with a multidisciplinary approach to gathering information on current regulations and considering potential solutions for market access in the Republic of Serbia, Montenegro and in other countries in the region.
Professional approach, fast and detailed preparation of the dossier enable a shorter registration procedure and faster obtaining a decision on the registration of your medical device.
We provide a high-quality professional translation service: Instructions for use (IFU), text for outer and inner packaging, marketing materials and other regulatory documents, certified by a medical doctor, if necessary.
Preparation of documentation for submission of the dossier to competent regulatory authorities in the Republic of Serbia, Montenegro and in other countries in the region.
Elimination of deficiencies during formal and expert assessment.
Professional and expert support during the entire duration of the procedure.
Our company is here to support you throughout the entire life cycle of your medical device by reporting any changes the manufacturer notifies you about.
Vigilance is an area where the significant improvements have already been achieved. Alignment with European regulations is ongoing, and we are here to help you further enhance your systems and processes to fully meet the new regulatory requirements.
Tiršova 5a, Savski Venac,
11 000 Belgrade, Serbia
Montenegro:
Dositejeva 75
85310 Budva, Crna Gora
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