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Halt GB, Donch JC, Stiles AR, VanLuvanee LJ, Theiss BR, Blue DL. FDA and intellectual property strategies for medical device technologies. New York, NY: Springer international publishing; 2019 Jan 24. pdf
Topics: medical device classification and regulatory pathways, device application preparation and submission, FDA review, product launch and postmarketing requirements, IP for medical device technology, trademarks and trade secrets, copyrights in medical device technology, design protection for medical device, medical device labeling and marketing, company's IP and regulatory strategy
Ogrodnik P. Medical device design: innovation from concept to market. Academic Press; 2019 Nov 8. pdf
Topics: medical devices classification, design process and product design specifics, design quality and realization, risk management and analysis, ISO 14971, product validation and verification, manufacturing supply chain, labeling and instructions for use, post market surveilliance, IP protection, regulatory approval to market
Pandey A, Gupta P, Sehgal NK. Artificial Intelligence in Medical Software. Springer; 2026 Apr 30. pdf
Topics: AI/ML-enabled medical devices, data management, performance metrics, model testing and validation, integration and deployment, security and privacy, medical device machine learning operation, regulatory requirements and risk management, AI-based health care applications, US FDA approval
Juuso I, Pöyhönen I. Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485. CRC Press; 2023 Nov 13.
Papademetris X, Quraishi AN, Licholai GP. Introduction to Medical Software: Foundations for Digital Health, Devices, and Diagnostics (Cambridge Texts in Biomedical Engineering). Cambridge University Press; July 14, 2022.
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Deep Learning and Convolutional Neural Networks for Medical Image Computing
Decision Forests for Computer Vision and Medical Image Analysis
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Artificial Intelligence and Image Processing in Medical Imaging
Computational Intelligence and Its Applications in Healthcare
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Leveraging AI and ML in Cardiovascular Diagnosis and Management
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