Technical File / Design Dossier

As an advisory company, we offer our clients technical support in developing medical devices and preparing necessary technical file and quality documentation.

Our offer includes e.g.:

  • choosing the right class of medical devices (I-III),
  • preparing complete technical file / design dossier for all medical devices (various purpose medical devices, IVD, AIMD etc.),
  • conducting bioequivalence studies in accordance with ISO 10933,
  • carrying out a review/audit of the documentation for compliance with legal requirements of Regulation (EC) No 2017/745 on medical devices and Regulation (EC) No 2017/746 on in vitro diagnostic medical device,
  • carrying out a review/audit of the documentation for compliance with legal requirements [the Act on medical devices (of 20 May 2010), Directive 90/385/EEC, 98/79/EEC, 093/42/EEC and MEDDEV guidelines) and the requirements of ISO standard 13485:2003],
  • preparing labels for a medical device,
  • preparing an notification or application for submission to URPL,WMiPB (Polish HA),
  • consultancy on ensuring compliance with the requirements of harmonised standards.