Senior Biomedical Consultant
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 FDA [IDE/510(k)/PMA], CE Mark, and other international submissions. He excels in developing robust regulatory strategies, managing global clinical trials,...
Experience: 16+ years
Submissions: 50 510(k), 5 De Novo, 10 PMA
Michael V. Ward provides regulatory consulting services to clients in:
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.
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.
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 FDA [IDE/510(k)/PMA], CE Mark, and other international...
With 16 years of executive leadership experience in the medical device industry, Michael V. Ward is an exceptionally valuable FDA regulatory consultant. His profound expertise spans complex regulatory pathways, including IDE, 510(k), and PMA submissions, alongside CE Mark and international requirements, demonstrating a comprehensive understanding of global market access. He excels in developing robust regulatory strategies, managing global clinical trials, and conducting critical safety assessments, evidenced by successfully achieving Breakthrough Device Designation for multiple companies and resolving challenging FDA concerns. His strong scientific foundation, including a background in pharmacology and immunology, coupled with extensive experience in cardiovascular, neurology, and IVD devices, allows him to provide insightful and actionable guidance for medtech professionals seeking to accelerate product development and market entry with confidence and efficiency.
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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