Experienced in the Coordination, Writing, Review, and Approval of all your Regulatory Documentation Requirements.
- Facility Registration Assistance
- Device Classification and Registration Assistance
- 510(k) Application Preparation
- Premarket Approval (PMA) Application Preparation
- Investigational Device Exemptions (IDE) Preparation
- CE Marking Consultation including Technical File Preparation
- Warning Letter and Form 483 Response Assistance
- Coordination of other Regulatory Documentation for World-Wide Registration
- Clinical Label Review and Approval
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