Expert Witness Profile

• 25+ expert witness projects in Federal and State court
• Testified in depositions and at trial; authored multiple expert reports
• Retained exclusively by prevailing side in all cases
• Specializing in FDA medical devices, biologics, pharmaceuticals, diagnostics, software medical devices (AI/ML), and combination products
• Clients include Johnson & Johnson, Pfizer, Merck, Boston Scientific, Baxter, Zimmer, Smith & Nephew

Expertise

• FDA & International Medical Product Regulations
• Regulatory Submissions: 510(k), PMA, INDs, EUAs
• Quality Systems (development, audits, compliance)
• Clinical trials (design, implementation, international)
• Product safety, labeling, risk management
• Software as a medical device (AI/ML)

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