IN

Intertek

FDA 510(k) Consulting

Intertek is a leading FDA regulatory consulting firm dedicated to supporting medical device companies. They specialize in guiding clients through the complexities of 510(k) submissions and developing robust regulatory strategies to achieve successful market entry and compliance.

Experience: 12+ years

Submissions: 45 510(k)

Expertise & Specializations

Regulatory Pathways

510kPmaDe NovoBreakthrough DevicesHumanitarian Device Exemption

Device Specialties

General HospitalCardiovascularNeurologyOrthopedicGastroenterology

Executive Summary

Professional Overview

Intertek is a leading FDA regulatory consulting firm dedicated to supporting medical device companies. They specialize in guiding clients through the complexities of 510(k) submissions and developing robust regulatory strategies to achieve successful market entry and compliance.

Core Specializations

Regulatory Pathways

510kPmaDe NovoBreakthrough DevicesHumanitarian Device Exemption

Device Specialties

General HospitalCardiovascularNeurologyOrthopedicGastroenterology

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Background: 12+ 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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