What services does Oberheiden P.C. offer?

Oberheiden P.C. 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 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 7+ years of experience, 35+ 510(k) submissions in FDA regulatory affairs.

Oberheiden P.C.

FDA Regulatory Consultant

Oberheiden P.C. specializes in FDA regulatory consulting for medical device companies, focusing on 510(k) submissions and regulatory strategy.

Experience: 7+ years

Submissions: 35 510(k)

Expertise & Specializations

Regulatory Pathways

510k

Device Specialties

General HospitalRadiologyCardiovascularOrthopedic

Executive Summary

Professional Overview

Oberheiden P.C. specializes in FDA regulatory consulting for medical device companies, focusing on 510(k) submissions and regulatory strategy.

Core Specializations

Regulatory Pathways

510k

Device Specialties

General HospitalRadiologyCardiovascularOrthopedic

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

Background: 7+ 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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