Medical Device RAQA Consulting Services

Rely on CIRO’s decades of experience in the Quality Assurance / Regulatory Assurance field to support you company. Our support will be tailored to your needs and can include:

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  • Quality Management System (QMS) development and maintenance
  • Regulatory Strategy
  • 510(k) Submissions
  • General Audits
  • FDA Response and Remediation
  • FDA Inspection Support
  • Due Diligence Reviews
  • Medical Device Reporting
  • CAPA Systems
  • Supplier Qualifications
  • EU MDR Requirements
  • ISO 13485 Support