What services does Oberheiden P.C. offer?

Oberheiden P.C. offers Regulatory Pathway Assessment, 510(k) Submission Authoring and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Oberheiden P.C. specialize in?

Oberheiden P.C. specializes in 510k and other FDA regulatory pathways for medical devices.

What is Oberheiden P.C.'s regulatory experience?

Oberheiden P.C. has 12+ years of experience in FDA regulatory affairs.

Oberheiden P.C.

Law Firm

Oberheiden P.C. is a distinguished law firm with extensive expertise in FDA 510(k) regulatory consulting. They provide comprehensive legal and compliance support for medical device companies, guiding them through complex FDA regulatory pathways and ensuring successful 510(k) clearances. Their services are specifically tailored to meet the intricate demands of the 510(k) submission process.

Experience: 12+ years

Expertise & Specializations

Regulatory Pathways

510k

Device Specialties

General-Hospital

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510k

Device Specialties

General-Hospital

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.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Background: 12+ years of regulatory experience.

Cruxi view

No information available to assess the consultant's strengths.

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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