What services does Elexes offer?

Elexes 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 Elexes specialize in?

Elexes specializes in 510k, De Novo, Breakthrough Devices and other FDA regulatory pathways for medical devices.

What is Elexes's regulatory experience?

Elexes has 12+ years of experience, 25+ 510(k) submissions in FDA regulatory affairs.

Elexes

Consulting Firm

Elexes is a specialized consulting firm dedicated to FDA 510(k) regulatory consulting, providing expert support for startups and established medical device companies. They offer comprehensive assistance with 510(k) submissions and De Novo applications, guiding clients through complex FDA regulatory pathways to achieve successful clearances. Serving clients globally, Elexes enhances the regulatory ...

Experience: 12+ years

Submissions: 25 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoBreakthrough Devices

Device Specialties

RadiologyGeneral-HospitalNeurology

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoBreakthrough Devices

Device Specialties

RadiologyGeneral-HospitalNeurology

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: 12+ years of regulatory experience.

Cruxi view

Elexes, represented by Team Elexes, focuses on providing guidance and tools for companies preparing for FDA inspections, particularly in the context of 21 CFR 820 and QSIT compliance. Their mock FDA inspection guide aims to help companies identify and correct gaps before regulatory audits, understand the correlation between inspections, scores, and audit performance, and apply industry best practices.

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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