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Springer Nature Switzerland
Reference109 articles.
1. F. Tettey, S. K. Parupelli, and S. Desai, “A Review of Biomedical Devices: Classification, Regulatory Guidelines, Human Factors, Software as a Medical Device, and Cybersecurity,” Biomedical Materials & Devices, no. August, 2023.
2. C. Peña, K. Li, R. Felten, N. Ogden, and M. Melkerson, “An example of US food and drug administration device regulation: Medical devices indicated for use in acute ischemic stroke,” Stroke, vol. 38, no. 6, pp. 1988–1992, 2007.
3. W. H. Organization, Medical device regulations: global overview and guiding principles. World Health Organization, 2003.
4. D. J. Jones and M. T. Masters, “11.1. 3 Medical Device Development Process,” in INCOSE International Symposium, 2008, vol. 18, no. 1, pp. 1215–1230.
5. L. H. Monsein, “Primer on medical device regulation. Part I. History and background.,” Radiology, vol. 205, no. 1, pp. 1–9, 1997.