Our Service

Our service:

  • Compliance
  • Complaints Management
  • Quality System Development:
      • QSR
      • EN ISO 13485
  • Product Approval
      • 510(k)
      • PMA
      • CE
  • CAPA Management
  • Supplier Management
  • Audits
      • Internal
      • Supplier
  • Risk Management
  • Response and Remediation of audit findings 483 and Notified Body.
  • Clinical Development
      • Site development worldwide
      • Site Management
      • Assist with Clinical protocol
      • Investigator relationship development