A systematic review in research of medical software certification




Huang, Qi

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During the past two decades, there has been an explosive volume of software applied in the field of heath care. As medical software becomes pervasive in all facets of health care services, the risk of software related patient injuries and patient deaths is also on the rise. To assure the quality of medical software, rigorous validation and verification methods must be employed to analyze all phases of development and final products. In this thesis, a systematic review was conducted to examine and summarize research in the area of medical software certification, which is the primary quality assurance approach taken by regulatory bodies. Key findings indicate that research in the field of medical software certification is sparse, with a limited range of focus and research methodologies. Greater effort using empirical research approaches is necessary for the improvement of current research in medical software certification.



medical software, certification, validation, clinical healthcare, certify