The Services

Pre-market. Getting ready for certification

  • Clinical Investigation Plans
  • Clinical Investigation Reports
  • Usability Study Plans & Reports
  • Systematic Literature Reviews
  • Inputs to Risk Management
  • Templates for various documents

MDR Certification Support

  • Clinical Development Plans
  • Clinical Evaluation Plans
  • Clinical Evaluation Reports
  • Post-Market Clinical
    Follow-up Plans
  • Gap analysis of Technical
    Documentation

Post-Market. Ongoing Compliance

  • Plans and Reports for PMCF studies
  • Periodic updates of Clinical Evaluations
  • Updated literature reviews & vigilance reports

Science Communication

  • Manuscripts for peer-reviewed journals
  • Abstracts for conferences
  • Posters and slide decks presentations
  • Blog posts