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CAROL PENNY HOUSTON — 510(k) & De Novo Consultant (IVD/Ophthalmic)

Founder & Principal Consultant

A highly accomplished and results-driven Regulatory Affairs Executive and Healthcare Law Strategist with over 25 years of global experience. Carol Penny Houston is a seasoned leader in navigating complex healthcare regulations, with a distinguished track record of successfully directing and securing over 15 FDA and multiple international regulatory submissions. She consistently achieves market cle...

Experience: 26+ years

Submissions: 20 510(k), 5 De Novo, 10 PMA

Expertise & Specializations

Regulatory Pathways

510(k)De NovoPMAQ-Sub

Device Specialties

IVDOphthalmicOrthopedicObgyn

Regions Served

CAROL PENNY HOUSTON provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Asia-PacificLatin AmericaMiddle East & Africa

Credentials & Recognition

Education & Credentials

Possesses advanced degrees from esteemed institutions, including a Master of Science in Bioscience Regulatory Affairs from Johns Hopkins University, a Master of Science in Health Law from Nova Southeastern University, and a Master of Business Administration with a focus on e-Business/e-Commerce from the University of Phoenix. This strong academic foundation, complemented by a Graduate Certificate in Medical Device Technologies, provides a comprehensive understanding of the scientific, legal, and business aspects crucial for navigating the complex regulatory landscape of the MedTech industry.

Recognized for thought leadership and industry engagement, with active participation in FDA and AdvaMed Women’s Health Policy meetings. Serves as an advocate and speaker on critical topics such as health equity, biotechnology innovation, and regulatory pathways, demonstrating a commitment to advancing the healthcare industry.

Certifications

HT (ASCP)
American Society of Clinical Pathologist
2000

Professional Experience

A seasoned Regulatory Affairs Executive with over 25 years of global experience, demonstrating a consistent track record of leadership in advancing medical technologies. Proven expertise in driving market clearances for over 15 FDA and multiple international regulatory submissions across Fortune 500 MedTech, Pharmaceutical, and Biotechnology companies, resulting in multimillion-dollar revenue growth. Successfully led regulatory, quality, and clinical strategies for innovative medical devices, biologics, and diagnostics, including software-based digital health solutions. Recognized for shaping policy and market access strategies that accelerate the delivery of safe and effective healthcare products worldwide.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

A highly accomplished and results-driven Regulatory Affairs Executive and Healthcare Law Strategist with over 25 years of global experience. Carol Penny Houston is a seasoned leader in navigating complex healthcare regulations, with a distinguished track record of successfully directing and securing...

Core Specializations

Regulatory Pathways

510(k)De NovoPMAQ-Sub

Device Specialties

IVDOphthalmicOrthopedicObgyn

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
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, CA, APAC, LATAM, MEA
  • Background: 26+ years of regulatory experience.

Cruxi view

With 26 years of experience in medtech, this consultant specializes in navigating complex healthcare regulations and has a distinguished track record of successfully directing and securing over 15 FDA and multiple international regulatory submissions. Their expertise in advancing medical technologies across diverse therapeutic areas, ensuring robust compliance, and accelerating the delivery of safe, effective, and transformative healthcare products worldwide is unparalleled. Their proficiency in digital health solutions, including SaMD, AI/ML-enabled systems, and cybersecurity requirements, makes them invaluable for modern MedTech innovation. They possess a remarkable 95% first-round market submission success rate, underscoring a deep understanding of regulatory pathways for medical devices, biologics, and diagnostics. Their unique combination of FDA experience, device expertise, and regulatory depth makes them a trusted advisor for MedTech companies.

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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