Charmaine Sutton

Charmaine Sutton’s consulting services focus on medical devices, diagnostics, and combination products. She has extensive experience advising medium, small, and start-up medical product developers and manufacturers on a broad range of U.S. Food and Drug Administration (FDA) regulations and EU medical product directives. During her consulting career Charmaine has helped numerous U.S. and European companies develop successful regulatory strategies for product approvals and manufacturing compliance. She helps prepare regulatory submissions (RFDs, IDEs, 510(k)s, PMAs), and leads companies through early collaboration meetings with the FDA. Charmaine designs and analyzes quality systems for FDA/QSR and ISO compliance, assists with post-market compliance matters (inspections, warning letters, removals / recalls, MDR / vigilance reporting), and helps develop quality and regulatory management.

Prior to consulting, Charmaine worked in industry and academic research and development. She held technical and clinical, quality, and regulatory management positions in several start-up medical device companies, and conducted applied research at a US national laboratory.

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