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DiGangi Consulting is a private medical device regulatory affairs consulting firm that advises manufacturers, investors, and early-stage companies on FDA strategy and regulatory pathways. The firm focuses on regulatory planning, submission support, and strategic assessment of development and commercialization tradeoffs for medical device programs. Its services appear oriented toward advisory work rather than proprietary therapeutic product development. Founded in 2003 by Donna DiGangi, the company operates as an independent consultancy serving the medtech and healthcare sector.
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