What services does Oriel STAT A MATRIX offer?

Oriel STAT A MATRIX 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 Oriel STAT A MATRIX specialize in?

Oriel STAT A MATRIX specializes in 510k, De Novo, Ide and other FDA regulatory pathways for medical devices.

What is Oriel STAT A MATRIX's regulatory experience?

Oriel STAT A MATRIX has 25+ years of experience, 75+ 510(k) submissions in FDA regulatory affairs.

Oriel STAT A MATRIX

FDA Regulatory Consultant

Oriel STAT A MATRIX specializes in FDA regulatory consulting for medical device companies, focusing on 510(k) submissions and regulatory strategy.

Experience: 25+ years

Submissions: 75 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoIdePre-SubmissionHde

Device Specialties

CardiovascularRadiology

Regions Served

Oriel STAT A MATRIX provides regulatory consulting services to clients in:

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

Executive Summary

Professional Overview

Oriel STAT A MATRIX specializes in FDA regulatory consulting for medical device companies, focusing on 510(k) submissions and regulatory strategy.

Core Specializations

Regulatory Pathways

510kDe NovoIdePre-SubmissionHde

Device Specialties

CardiovascularRadiology

Services Offered

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: 25+ years of regulatory experience.

Cruxi view

Oriel STAT A MATRIX is a consulting firm specializing in FDA 510(k) submissions for medical devices. They have a presence in both the EU and Washington, indicating a broad geographical reach.

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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