Consultation Services

  • Feasibility studies for factories and projects
  • Cost reduction projects
  • Build medical devices factories
  • Purchasing machines and production line with the best cost profit
  • Preparation of laboratories chemical, physical and microbiological
  • Establishment ISO 13485 and CE mark management system
  • Market studies

Consultation Services

  • Technical file preparation for medical devices
  • Risk management for product and processes
  • Clinical evaluation reports for all medical devices products
  • Biocompatibility evaluation reports
  • Gap analysis and assessment


  • Carry out clean rooms validation according to ISO 14644-1
  • Carry out sterilization process validation which includes:
  • Sterilization by ETO according to ISO 11135
  • Sterilization by Gamma radiation according to ISO 11137
  • Software validation Carry out biocompatibility studies in accredited lab
  • Carry out stability and package test validation in accredited lab

Training services

  • Carry out training activities for all ISO and management standards (ISO 9001, 14001, 45001, 50001, 22001)
  • Risk management according to ISO 14971:2012
  • Clinical evaluation training according to Meddev.
  • ISO 13485 implementation and requirements
  • CE mark MDD and new MDR requirements
  • Soft skills training


  • We can support companies to get quality management certificates
  • We have agreement and agent for HTCERT and RINA Italy co. for ISO 9001, ISO 13485 and CE