​​​​​​Allegiance Regulatory Consulting

Develop Product Development Regulatory Strategy:

  • Registration
  • Design Control
  • Validation Testing
  • Regulatory Agency Expectations

Write & Submit Registration Applications:

  • FDA 510(k) Clearance
  • 510(k) Transfers
  • European Union Technical Documentation
  • Health Canada Medical Device Licenses, Amendments & Additions
  • Global Submissions Advice (e.g. China, Taiwan, Thailand, Japan, Australia, New Zealand, Mexico, Brazil, etc.)

Create Compliant Quality Management System (QMS)

Perform Compliance Audits:

  • Quality Management Systems to Global Requirements
  • Product Labeling
  • Marketing Materials
  • Global Regulatory Documentation (e.g. DHF, Technical File, Risk Management Files, Clinical Data Reports, etc.)

Assist with Regulatory Authority Interactions:

  • FDA – CDRH
  • Health Canada Medical Devices Bureau
  • European Union Notified Bodies

Provide Regulations Training:

  • Establishment & Device Listing
  • Quality Systems
  • Design Control
  • 510(k) Documentation
  • Technical File Requirements
  • Risk Management Reports
  • Clinical Data Reports