Mansour Consulting LLC
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    • Medical Device Evaluation
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    • UDI Compliance
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    • Integrated Software Solution

Research and Development

Laboratory Testing

Patent Applications

Strategic Planning,

510K Submissions

FDA 483 and Warning Letters

Validation (including software)

Evaluate you product's regulatory needs for one flat fee at www.510kdevicesubmissions.com

21 CFR 820

ISO 13485

Technical Files

CE Mark

Audits

Unique Device Identification Compliance Assistance:

Set-Up

Data Management

Maintenance

www.medicaldeviceudi.com

US Agent

Official Correspondent

Registration and Listing

Import/Export

Certificate to Foreign Government

FDA Inspections

ERP, Document management system, training, labeling, and UDI

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