Dossier preparation and translation
The technical file, instructions for use and labelling in Uzbek and Russian.
Dossier preparation and translation
Most rejections are documentation problems rather than product problems. We build the registration dossier from your existing technical documentation — device description and variants, essential principles and standards, risk management, design verification and validation, biocompatibility and electrical safety reports, sterilisation and shelf-life data, clinical evaluation, manufacturing and quality system evidence — and identify what is missing before submission rather than after. Translation is done by regulatory translators and reviewed against the source: instructions for use and labelling in Uzbek and Russian, with consistent terminology across the whole file, plus notarisation, apostille and legalisation of the originals where these are required.
