Kapstone Medical LLC is a full-service provider based in Waxhaw, NC, specializing in medical device consulting and product realization for pre- and post-market medical devices in the US and EU. With a proven track record of commercializing products worldwide, they offer a range of services including new product development, design engineering, prototyping, testing, quality assurance, regulatory affairs, manufacturing, supply chain management, and commercialization support. Their team of experts adapts their model to meet the unique needs of each client, providing a single-source solution to navigate the complex journey to market.
With over 110 customers served, 150 products launched, and 75 regulatory submissions, Kapstone Medical is dedicated to inspiring, equipping, and guiding medical device companies to success. They have a deep understanding of international regulatory requirements and can assist with regulatory strategies, submissions, compliance, remediation, and training. Additionally, their manufacturing services include finding appropriate suppliers, managing the production process, and providing competitive prototyping and production quotes. Committed to their clients' success, Kapstone Medical offers comprehensive commercialization support services, from business strategy and market entry to product launch and ongoing operations.
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