PubMed Literature
Medical device publications from PubMed / NCBI
Impact of the Regulatory Framework on Medical Device Software Manufacturers: Are the Guidance Documents Supporting the Practical Implementation? Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".
Read More →Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices: A Systematic Review.
Read More →Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges.
Read More →Comparison of the international regulations for medical devices-USA versus Europe.
Read More →Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review.
Read More →Regulatory Framework for Implantable Neurostimulation Devices: Comparison of Systems in the US and European Union.
Read More →An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection.
Read More →[Roadmap of Medical Device for Implanted Brain-computer Interface].
Read More →Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study.
Read More →Digital Tools-Regulatory Considerations for Application in Clinical Trials.
Read More →US regulatory considerations for low field magnetic resonance imaging systems.
Read More →No matching articles.
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