Services

EU MDR implementation

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  • Gap Analysis
  • Reclassification
  • Update Technical Documentation
  • GSPR development
  • Clinical Evaluation

Regulatory and Quality

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  •   Complaints Management
  • Quality System Development
    • QSR
    • EN ISO 12485
  • 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

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  • Site development worldwide
  • Site Management
  • Assist with Clinical protocol
  • Investigator relationship development