• USA FDA agent
  • US FDA 510(k) & PMA & De Novo
  • US FDA Emmergency Use Authorizations (EUA) during COVID19 Pandemic
  • EU CE mark, MDD & MDR compliance
  • China NMPA (cFDA) approval
  • Japan MHLW approval
  • US QSR & ISO 13485 compliance, FDA audit, MDSAP audit
  • EU ROHS 2, REACH, WEEE compliance
  • China GB standards testing & PTR (product technical requirement)
  • UDI compliance, GUDID registration
  • ISO 14971, IEC 60601, IEC 62304, IEC 62366, Human Factor Usability Testing
  • Post-market surveillance & event reporting programs
  • Special topic:
    • FDA cyber-security guidance
    • FDA mobile medical application & digital health program
  • Value proposition / Market research
  • SWOT / PEST analysis & competitive landscape
  • Digital marketing / engagement
  • Outbound / Inbound marketing plans
  • Sales channel expansion into US, China and EU markets
  • Medical device import/export matters
  • Investor relations & fundraising
  • Roadshows