What services does Haewon Park offer?

Haewon Park offers Regulatory Pathway Assessment, De Novo & PMA Strategy and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Haewon Park specialize in?

Haewon Park specializes in 510k, De Novo, Q Sub and other FDA regulatory pathways for medical devices.

What is Haewon Park's regulatory experience?

Haewon Park has 5+ years of experience, 3+ 510(k) submissions in FDA regulatory affairs.

Haewon Park

Regulatory Affairs Consultant

Regulatory Affairs Consultant with 5+ years of experience leading 510(k) submissions, Q-Submissions, and post-market compliance for medical devices, cosmetics, and consumer health technologies. Expertise in Class II devices and a Ph.D. in Environmental Science enable me to provide end-to-end support, including regulatory gap analysis, submission strategy, labeling/claims review, and quality docume...

Experience: 5+ years

Submissions: 3 510(k), 1 De Novo

Expertise & Specializations

Regulatory Pathways

510kDe NovoQ Sub

Device Specialties

CardiovascularOphthalmicGeneral Hospital

Regions Served

Haewon Park provides regulatory consulting services to clients in:

United States (FDA)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoQ Sub

Device Specialties

CardiovascularOphthalmicGeneral Hospital

Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

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

Haewon Park offers a valuable blend of scientific rigor and practical regulatory experience, particularly beneficial for companies navigating the U.S. FDA landscape. With 5+ years of experience focused on 510(k) submissions, Q-Submissions, and post-market compliance, coupled with a Ph.D. in Environmental Science, she brings a deep understanding of both the scientific and regulatory aspects of medical devices, cosmetics (MoCRA), and consumer health technologies. Her specialization in Class II devices across cardiovascular, ophthalmic, software-as-a-medical-device (SaMD), and general hospital applications makes her a well-rounded consultant for a variety of projects. The ability to communicate in both English and Korean further enhances her value for international clients, especially those based in Korea.

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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