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© 2026 cohaga AG · All Rights Reserved · St. Gallen, Switzerland · Imprint742,806 companies indexed · Last updated: today
DirectoryBusiness & Technical ServicesManagement ConsultingEcublens VdMansour Consulting
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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.

AI-generated
Offering

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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Location

Route du Bois 49 b
1024 Ecublens Vd

At a glance

Legal form
Sole proprietorship
UID
CHE-453.162.146
Founded
2021 · 5 years
Last commercial register change
February 24, 2026
Employees
1 to 10

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