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Mansour Consulting

Summary

About the company

The core activity of Mansour Consulting LLC is to provide services to medical device manufacturers, particularly in the areas of: regulatory consulting and support, including FDA approvals and inspections; quality management systems and auditing; UDI compliance (Unique Device Identification); technical support for communication with external partners; medical device evaluation and approval; and development and implementation of integrated software solutions for the medical device industry. The company also offers specialized services such as creating technical files, CE markings and import/export certificates.

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Products & services

Industry:Management Consulting

✓ Offered7

Regulatory Assistance

Regulatory strategy, 510(k) preparation, FDA 483 and Warning Letter responses, software validation, pre-submission planning, and international regulatory strategy.

Quality Systems

QMS design and implementation under 21 CFR Part 820 and ISO 13485, including SOPs, CAPA, complaint handling, internal audits, and CE Mark technical files.

FDA Representation

US Agent and Official Correspondent services, FDA establishment registration, device listing, import/export support, Certificate to Foreign Government, and inspection communications.

UDI Compliance

End-to-end Unique Device Identification compliance for FDA GUDID and EU EUDAMED, including setup, bulk submissions, labeling review, and ongoing data maintenance.

Medical Device Evaluation

Flat-fee regulatory assessment covering device classification, submission pathway, predicate identification, testing requirements, and a written roadmap for market entry.

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Mansour Consulting

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