History
After developing strong regulatory expertise at a large orthopedic manufacturer Nathan Wolf recognized the need for this proficiency at a variety of local medical device companies and innovators, and established Wolf Regulatory Consulting. The firm is dedicated to sharing the energy and passion we have for our craft with clients who are equally driven in their ambitions as creators and innovators.
Wolf Regulatory Consulting opened its doors in 2015, and has a consistent track record of success for a wide variety of medical device clients. Today, Wolf Regulatory Consulting is based in Phoenix, Arizona, and provides ongoing support for clients across the west coast and throughout the world. We're dedicated to providing our clients with an exceptional level of enthusiasm and vision, as well as a deep, nuanced understanding of the regulatory landscape for their product.
Get in touch
We're confident we have the passion and regulatory know-how to make your project an unequivocal success, and we're excited to discuss your regulatory plans.
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Principal Consultant
Nathan Wolf
Nathan Wolf founded Wolf Regulatory Consulting to build upon his experience leading regulatory and cross-functional (clinical, design, and quality) initiatives at Acumed LLC, a Portland, Oregon based orthopedic manufacturer. Mr. Wolf is well-versed in global regulatory requirements, having prepared product registration applications for regulatory bodies around the world. He has worked with individual innovators, startups, and mid-sized companies to establish and execute ambitious regulatory strategies for both novel products and established device portfolios. Nathan graduated magna cum laude from Bucknell University's widely acclaimed Department of Biomedical Engineering Department.
Industry Partners
Wolf Regulatory Consulting has a strong network of collaborative regulatory and medical device industry partners, including regulatory, engineering, quality, and compliance teams. Leveraging this network enables us to scale effective team size and orient expertise to address nearly any client need. Wolf Regulatory has a small core team, but is mighty enough to tackle any regulatory project you may have!