Medical Devices Support

Clinres farmacija offers a comprehensive set of medical device related services. As diverse this field may be, so are our service packages to fit your requirements. From device clinical trials and market research to post-marketing reporting, there is little a medical device manufacturer or marketing authorization holder needs left uncovered in our service portfolio.

  • Gap analysis MDD/IVDD vs MDR/IVDR
  • Labeling of medical device (EU, USA, rest of the world)
  • Unique Device Identification (UDI): implementation, entrance in databases (e.g. FDA GUIDID)
  • Technical documentation according to MDR/IVDR
  • Common Submission Dossier Template (cSDT) – summary of technical documentation required for registrations in ASEA countries
  • Table of Content (ToC) format of registration application (currently required only by Health Canada, but a part of harmonization effort led by the International Medical Device Regulators Forum (IMDRF))
  • Classification of MDs/IVDs in various jurisdictions (EU, USA, CA, AU, ASEAN…)
  • Software standards and regulations: IEC62304; Software as Medical Device (SaMD) – classification, clinical evidence.
  • Evaluation of product changes, defining significant changes, change notifications to the authorities worldwide
  • Clinical (Performance) Evaluation and Reports
  • Medical device single audit program (MDSAP)
  • Preparation of registration applications (US 510(k), ASEAN countries, Latin American countries)
  • Vigilance of medical devices (EU, USA, AU, BR, CA, APAC countries): establishing SOPs, assistance in reporting
  • Post-market surveillance (PMS) according to MDR/IVDR: SOP, template for PMS plan and report; Post-market clinical follow-up (PMCF) and Post-market performance follow-up (PMPF) plan and report
  • Risk management according to ISO 14971
  • Design control according to 21 CFR 820.30