Services

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EU MDR implementation

Regulatory and Quality

Regulatory and Quality

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

Regulatory and Quality

Regulatory and Quality

Regulatory and Quality

•   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

Regulatory and Quality

Clinical Development

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