What services does ICON plc offer?

ICON plc offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does ICON plc specialize in?

ICON plc specializes in 510k, Pma, De Novo and other FDA regulatory pathways for medical devices.

What is ICON plc's regulatory experience?

ICON plc has 15+ years of experience, 45+ 510(k) submissions in FDA regulatory affairs.

ICON plc

ICON plc's medical device & IVD regulatory experts offer a deep understanding of applicable regulations and requirements, extending beyond published guidance to help clients navigate complex global landscapes. They specialize in ensuring compliance and facilitating market access for a wide range of medical technologies.

Experience: 15+ years

Submissions: 45 510(k)

Expertise & Specializations

Regulatory Pathways

510kPmaDe NovoIde

Device Specialties

Ivd

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kPmaDe NovoIde

Device Specialties

Ivd

Services Offered

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: 15+ years of regulatory experience.

Cruxi view

ICON plc provides regulatory affairs consulting for medical devices and IVDs, helping clients navigate complex regulations and requirements. Their expertise extends beyond published guidance, offering a deep understanding of applicable regulations.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

Contact ICON plc

Share a brief overview of your device and timeline. Cruxi will forward your request to ICON plc and help structure next steps.

Contact Now