Литература PubMed
Публикации о медицинских изделиях из PubMed / NCBI
Multicenter Clinical Performance Evaluation of Omadacycline Susceptibility Testing of Enterobacterales on VITEK 2 Systems.
Читать далее →FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate.
Читать далее →Artificial intelligence in medicine - dermatology compared to other medical specialties in FDA-cleared software as medical device.
Читать далее →Risk of Recall Associated With Modifications to High-risk Medical Devices Approved Through US Food and Drug Administration Supplements.
Читать далее →Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device.
Читать далее →Bayesian Statistics for Medical Devices: Progress Since 2010.
Читать далее →Неразрешимый анализ риска безопасности пациентов от парентеральных лекарств и медицинского оборудования, содержащих эндотоксин.
Читать далее →Regulatory scripting: Stakeholder participation in food and drug administration medical device advisory meetings.
Читать далее →Propensity score-based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation.
Читать далее →Review of approvals and recalls of US specific medical devices in general and plastic surgery.
Читать далее →Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018.
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