Cindy Van Duker is a focused, quality-driven regulatory professional with 25+ years of experience within diverse manufacturing environments. She is highly skilled at regulatory submissions and has strong knowledge of guidance under ISO 13485 and FDA’s Quality System Regulations (QSR). Experience with EUAs, Pre-Submissions, IDEs, PMAs, 510(k)s, CE Design Dossiers, Technical Files, Canadian Licenses, ROW registrations, and China and Japan Submissions.

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In her leisure time, Cindy enjoys spending time with her family including her dog, hiking, and experiencing new cultures with adventurous travel.