Services

Medical Devices

  • Clinical Evaluation Plan (CEP)
  • Clinical Evaluation Report (CER)
  • Clinical Development Plan
  • Literature Review Plan
  • Literature Review Report
  • Device Description
  • Instructions for Use (IFU)
  • Summary of Safety and Clinical Performance (SSCP)
  • Post-market surveillance Plan (PMSP)
  • Post-market surveillance report (PMSR)
  • Periodic Safety Update Report (PSUR)

IVDs

  • Literature Review Plan
  • Literature Review Report
  • Device Description
  • Instructions for Use (IFU)
  • Analytical Performance Study Plan
  • Analytical Performance Study Report
  • Performance Evaluation Plan (PEP)
  • Performance Evaluation Report (PER)
  • Scientific Validity Report
  • Analytical Performance Report
  • Clinical Performance Report
  • Summary of Safety and Performance (SSP)
  • Post-market Performance Follow-up Plan (PMPFP)
  • Post-market Performance Follow-up Report (PMPFR)
  • Post-market Surveillance Plan (PMSP)
  • Post-market Surveillance Report (PMSR)
  • Periodic Safety Update Report (PSUR)
  • Clinical Investigation Plan (CIP) – Clinical Study Protocol (CSP)
  • Clinical Investigation Report (CIR) – Clinical Study Report (CSR)
  • Investigator’s brochure (IB)
  • Informed Consent Form (ICF)
  • Case Report Form (CRF)
  • Abstracts
  • Articles
  • Scientific Communication