Our

Services

​​​​​​​​​​​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