Intertek
Regulatory Consultant
Intertek is a distinguished full-service CRO and global testing organization with extensive expertise in FDA 510(k) regulatory consulting. They specialize in providing comprehensive 510(k) consulting and training services, empowering medical device companies to successfully navigate complex FDA regulatory pathways and achieve timely clearances. Intertek serves clients across the US, EU, and global...
Experience: 15+ years
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
Intertek provides regulatory consulting services to clients in:
Executive Summary
Professional Overview
Intertek is a distinguished full-service CRO and global testing organization with extensive expertise in FDA 510(k) regulatory consulting. They specialize in providing comprehensive 510(k) consulting and training services, empowering medical device companies to successfully navigate complex FDA regu...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Cruxi Independent Snapshot
Best suited for
- • MedTech companies seeking expert regulatory guidance
Experience signals
- Regions: US, EU
- Background: 15+ years of regulatory experience.
Cruxi view
Intertek offers FDA 510(k) consulting services, focusing on efficient navigation of the submission process. Their expertise lies in helping companies achieve market success through FDA clearance.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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