What services does Veranex offer?

Veranex 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 Veranex specialize in?

Veranex specializes in 510k, Pma and other FDA regulatory pathways for medical devices.

What is Veranex's regulatory experience?

Veranex has 15+ years of experience in FDA regulatory affairs.

Veranex

Consultant

Veranex is a distinguished full-service CRO with 15 years of dedicated experience in the medtech industry. They specialize in providing end-to-end services that encompass product design, regulatory affairs, and commercialization strategies. Their core expertise lies in navigating the complex FDA regulatory landscape, particularly with a strong focus on FDA 510(k) submissions and achieving successf...

Experience: 15+ years

Expertise & Specializations

Regulatory Pathways

510kPma

Regions Served

Veranex provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kPma

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.

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

Regions: US, EU
Background: 15+ years of regulatory experience.

Cruxi view

Veranex distinguishes itself as a full-service CRO with 15 years of experience, offering a unique end-to-end medtech service model encompassing design, regulatory, and commercialization. Their core strength lies in FDA 510(k) regulatory consulting, specializing in successful clearances for Class I and Class II medical devices, including the nuanced area of Software as a Medical Device (SaMD). This comprehensive offering, coupled with their experience in PMA submissions and a global service footprint (US, EU, Global), positions them as a strategic partner capable of guiding clients through complex regulatory landscapes from concept to market.

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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