Services

Product Development & Design Controls:

• Planning the Design Process
• Product Requirements Documents
• Design Inputs and Outputs
• Verification / Validation of Design
• Design Changes
• Design Review and History Files
• Advanced Tools / Guidance
• Premarket Regulatory Approval

Compliance & Quality Systems:

• Quality Management Systems
• Internal and Supplier Auditing
• FDA / Third-Party Audit Support
• Hot Topic! Canadian Medical Device Conformity Assessment System (CMDCAS)
• Global Complaint Handling
• Corrective/Preventive Action
• Management Responsibility
• Process Control
• Custom Automated Quality Tools

Regulatory Affairs & Crisis Intervention:

• Global Regulatory Submissions
• United States: IDE, 510(k), PMA & PMA Supplements, BLA, NDA
• CE Marking, European Technical Files and Design Dossiers
• Hot Topic!  Canadian Device Licenses
• Japanese Shonin / other Asian approval
• Miscellaneous Markets: Latin American, Australia, others.

• Worldwide Adverse Event Reporting
• Recalls and Safety Alerts
• FDA 483 / Warning Letter resolution
• Liaison with Regulatory Authorities
• Advertising and Promotion
• Import/Export
• Device Listings / Establishment Registration

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