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i3cglobal

i3cglobal is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. They possess deep expertise in navigating complex regulatory pathways, with a strong focus on 510(k) submissions and developing robust regulatory strategies. Their services extend to comprehensive support for quality management systems and international regulatory compliance, including EU M...

Experience: 7+ years

Submissions: 15 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPre-SubmissionIde

Device Specialties

General SurgeryCardiovascularNeurologyOrthopedicGastroenterology

Executive Summary

Professional Overview

i3cglobal is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. They possess deep expertise in navigating complex regulatory pathways, with a strong focus on 510(k) submissions and developing robust regulatory strategies. Their services extend to comprehe...

Core Specializations

Regulatory Pathways

510kDe NovoPre-SubmissionIde

Device Specialties

General SurgeryCardiovascularNeurologyOrthopedicGastroenterology

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: 7+ years of regulatory experience.

Cruxi view

This consultant specializes in FDA 510(k) submissions for medical devices and IVDs. They provide services to help navigate the regulatory pathway. Their LinkedIn presence suggests a broader scope of services beyond just 510(k) consulting.

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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