AI-powered regulatory consulting service that accelerates medical device market entry across 15+ countries. Combines in-country representation, dossier compilation, translation, and post-market compliance support to streamline global regulatory approval processes. Flat annual fee model starting at $...
Manufactured by
Pure Global
Jersey City, NJ, United States
Pure Global assists medical device and IVD companies with global market access, combining real-world experience with AI and data to deliver efficient regulatory compliance solutions. The company offers a turnkey solution that includes local representation, product registration, post-market compliance, and commercial support services across 30 countries through an extensive network of local entities and trusted partners. Through pureglobal.ai we offer free AI tools for medical device companies, including global device registries, device classification, regulatory intelligence, and even an annual fee calculator.
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Kanjin Health · China
Regulatory consulting and distribution partnership services enabling international medical device manufacturers to enter Canadian and global markets. Provides expertise in regulatory pathways, market access strategy, and distribution network development for health technology companies.
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seleon GmbH · Germany
Startup consulting service for medical device companies covering product development, manufacturing, and regulatory approval. Leverages multidisciplinary expertise including engineering, clinical medicine, and quality management to guide complex medical technology projects from concept to market.
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