1. Pashkov, V., Gutorova, N., Harkusha, A.: Medical device software: defining key terms. Wiadomości Lekarskie 69(6), 813–817 (2016)
2. IMDRF: “Software as a Medical Device”: Possible Framework for Risk Categorization and Corresponding Considerations 30 (2014)
3. Ronquillo, J.G., Zuckerman, D.M.: Software-related recalls of health information technology and other medical devices: implications for FDA regulation of digital health. Milbank Q. 95, 535–553 (2017). https://doi.org/10.1111/1468-0009.12278
4. Shroff, V., Reid, L., Richardson, I.: A Proposed Framework for Software Quality in the Healthcare and Medical Industry 8 (2011)
5. Alemzadeh, H., Iyer, R.K., Kalbarczyk, Z., Raman, J.: Analysis of safety-critical computer failures in medical devices. IEEE Secur. Priv. 11, 14–26 (2013). https://doi.org/10.1109/MSP.2013.49