DEBORAH MORLEY — 510(k) & PMA Consultant (Cardiovascular/IVD)
President and Principal Consultant
Dr. Deborah Morley is a distinguished Regulatory and Clinical Affairs expert with over 30 years of experience in the medical technology industry. She guides startups and established companies through complex regulatory pathways, specializing in strategic planning, PMA, 510(k), and Q-Submission preparation, and clinical trial management. Dr. Morley adeptly navigates global regulatory requirements, ...
Experience: 30+ years
Submissions: 3 510(k), 1 De Novo, 10 PMA
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
DEBORAH MORLEY provides regulatory consulting services to clients in:
Credentials & Recognition
Education & Credentials
Dr. Morley holds a Ph.D. in Anatomy/Medical Physiology with an emphasis on Cardiovascular Physiology from Bowman Gray School of Medicine, complemented by Master's and Bachelor's degrees in related fields. Her advanced scientific education, including post-doctoral fellowships in Cardiovascular Physiology and Heart Failure, provides a robust foundation for understanding complex medical devices. This strong academic background directly enhances her ability to interpret intricate technical data and engage effectively with scientific and clinical teams in the medical technology sector.
Dr. Morley has contributed to the scientific community through numerous publications in peer-reviewed journals, including the Journal of Thoracic and Cardiovascular Surgery and European Journal of Heart Failure, showcasing her thought leadership and research contributions. She has also served as a Section Editor for the ASAIO Website and as a reviewer for prominent journals like the ASAIO Journal and the Journal of Heart and Lung Transplantation, demonstrating her active engagement and standing within the field.
Professional Experience
With extensive experience spanning over three decades, Dr. Morley is a highly accomplished leader in regulatory and clinical affairs for medical technology companies. She has held senior leadership positions, including Vice President and Director roles, at prominent organizations, guiding them through critical regulatory milestones. Her career showcases a consistent track record of successfully navigating complex regulatory landscapes, securing vital product approvals, and managing global regulatory strategies. Dr. Morley's experience extends from advising startups to large medical device manufacturers, demonstrating a comprehensive understanding of the industry's evolving needs and challenges.
Executive Summary
Professional Overview
Dr. Deborah Morley is a distinguished Regulatory and Clinical Affairs expert with over 30 years of experience in the medical technology industry. She guides startups and established companies through complex regulatory pathways, specializing in strategic planning, PMA, 510(k), and Q-Submission prepa...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
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: 30+ years of regulatory experience.
Cruxi view
Dr. Deborah Morley offers a rare and powerful combination of deep scientific expertise and seasoned regulatory leadership, refined over 30 years in the medical technology industry. Her Ph.D. in Cardiovascular Physiology provides a profound understanding of complex device mechanisms, which she masterfully applies to regulatory strategy, particularly for high-risk Class III cardiovascular and IVD products. With an exceptional track record that includes successfully guiding 10 PMA submissions and securing multiple Breakthrough Device Designations, she excels at navigating the most demanding FDA pathways. For medtech companies, this translates into a strategic partner who can de-risk development, manage clinical trials, and lead global commercialization efforts with unparalleled scientific and regulatory authority.
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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