Michael V. Ward — 510(k) & PMA Consultant (Cardiovascular/Neurology)
Senior Biomedical Consultant and U.S. Agent for China Medical Device companies
Highly accomplished and results-driven Clinical & Regulatory Professional with extensive executive leadership experience in the medical device industry. Dr. Ward possesses a profound expertise in navigating complex regulatory pathways, including two decades of successful FDA [IDE/510(k)/PMA], CE Mark, and other international submissions and interactions with reviewers. He has represented several ...
Experience: 16+ years
Submissions: 50 510(k), 10 De Novo, 15 PMA
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
Michael V. Ward provides regulatory consulting services to clients in:
Credentials & Recognition
Education & Credentials
Holds a Doctor of Veterinary Medicine and pursued a concurrent MSc in Pharmacology from the Ontario Veterinary College, University of Guelph, Canada. Further enhanced expertise with a Post-doctoral Fellowship in Hemostasis and Immunology from the U.S. National Institute of Health & NY State Department of Health. This strong scientific foundation in biology, pharmacology, and immunology directly informs and strengthens their regulatory and clinical assessments for complex medical devices.
Recognized with a Baxter Healthcare Technical & Invention Award and multiple Johnson & Johnson awards, including Global Leadership Awards, highlighting significant contributions and innovation. Invited as a speaker at the China International Medical Device Regulatory Forum, underscoring thought leadership and international influence in the medical device regulatory space.
Certifications
NEMKO
2020
OHRP
2021
Professional Experience
A seasoned Clinical & Regulatory Professional with extensive executive leadership experience across multiple leading medical device companies. Demonstrated success in managing global clinical trials, navigating complex regulatory pathways including FDA [IDE/510(k)/PMA] and CE Mark submissions, and conducting thorough biocompatibility and safety assessments. Proven ability to secure Breakthrough Device Designations and resolve critical FDA concerns, showcasing a robust track record in accelerating product development and market entry.
Enterprise experience
Executive Summary
Professional Overview
Highly accomplished and results-driven Clinical & Regulatory Professional with extensive executive leadership experience in the medical device industry. Dr. Ward possesses a profound expertise in navigating complex regulatory pathways, including two decades of successful FDA [IDE/510(k)/PMA], CE Mar...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
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.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
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, APAC, CA
- Background: 16+ years of regulatory experience.
Cruxi view
With 16 years of experience and an executive leadership background, Dr. Ward provides a rare fusion of deep scientific knowledge and strategic regulatory acumen. His strong foundation in pharmacology and immunology, combined with a proven track record of 50 510(k)s, 15 PMAs, and 10 De Novo submissions, showcases his mastery over the entire spectrum of FDA pathways. He demonstrates exceptional proficiency with high-risk Class II and III devices, particularly in cardiovascular and neurology, and has successfully resolved critical, multi-year FDA concerns. As a dedicated U.S. Agent, his specialized expertise in guiding China-based medtech companies through complex U.S. approvals, including Breakthrough Device Designations, makes him a uniquely valuable and highly effective strategic partner for securing market access.
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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