Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association - Kühler, Thomas C.; Schoenmakers, Marc; Shergold, Oliver; Affolter, Stephan; Bolislis, Winona Rei; Foster, Ruth; Gardner, Paul; Hruschka, Svenja; Jomini, Thierry; Kaveripakam, Sathish; Mayerhofer, Karl; Scherini, Tomaso; et al. (Clinical therapeutics, 2022)
Keywords: Artificial intelligence; Combination products; Competent authority; Conformity; connected combined products; Connectivity; Cybersecurity; digital health; Drug delivery; Drug delivery systems; Internal Medicine; Legislation; Life cycles; Medical device industry; medical devices; Medical equipment; Medical technology; medicinal products; Patients; Regulation; Regulatory approval; Smartphones; Software; Usability; Working groups; medicinal products; digital health; medical devices; software; Combination products; connected combined products