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, Pma and other FDA regulatory pathways for medical devices.

What is Elexes's regulatory experience?

Elexes has 5+ years of experience, 10+ 510(k) submissions in FDA regulatory affairs.

Elexes

Elexes is a premier FDA regulatory consulting firm dedicated to empowering medical device and In Vitro Diagnostic (IVD) companies. With a specialized focus on 510(k) submissions and comprehensive regulatory strategy, our seasoned team provides unparalleled expertise to navigate complex FDA pathways. We are committed to accelerating your market access through meticulous planning, expertly crafted s...

Experience: 5+ years

Submissions: 10 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaQ Sub

Device Specialties

Ivd

Regions Served

Elexes provides regulatory consulting services to clients in:

United States (FDA)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoPmaQ Sub

Device Specialties

Ivd

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

Regions: US
Background: 5+ years of regulatory experience.

Cruxi view

Elexes is a premier FDA regulatory consulting firm, renowned for its in-depth expertise in medtech regulatory strategy. Their seasoned team has successfully navigated complex FDA pathways, with a notable 10 submissions under their belt, highlighting their efficiency in accelerating market access. With a specialized focus on 510(k) submissions and comprehensive regulatory planning, Elexes provides unparalleled guidance to medical device and IVD companies. Their commitment to meticulous planning, expertly crafted submissions, and robust quality system support makes them an invaluable asset to medtech professionals seeking regulatory success. Elexes' firm excels in guiding clients through every stage of the regulatory process, ensuring compliance and maximizing success for innovative medical technologies.

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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