Medical Device Development with Automated DevOps Environments and Regulatory Compliance
DOI:
https://doi.org/10.63282/3117-5481/AIJCST-V8I3P107Keywords:
Medical Device Development, Devops, Regulatory Compliance, Healthcare Monitoring, Medical Software LifecycleAbstract
The demand for reliable, safe, and compliant software-driven medical device development environments has increased with the changing dynamics in the field of healthcare technologies. It also has the need for patient safety and software reliability. The typical medical device software development process may involve a number of problems, including multiple testing environments, slow deployment cycles, lack of visibility, and compliance issues. A medical monitoring framework was established to overcome these challenges, which allowed for the automation of all aspects of DevOps, such as continuous integration, continuous deployment, medical services containerization, automated testing, vulnerability assessment, real-time monitoring and compliance auditing. It utilises some of the most important technologies, including Docker, Prometheus, Grafana, GitHub Actions, and cloud-native deployment methods, to improve the efficiency of software delivery and monitoring. Results of the experiment showed effective utilization of the infrastructure with an average of 1.99% CPU consumption, 376.2 MB memory consumption and application programming interface (API) response time of 1.9–3.1 ms for eight containers deployed. The system alerted 220 alerts and resolved 111 alerts (alert resolution rate = 50.5%) for continuous patient monitoring and clinical intervention. Implementation Mapping with recognised medical and cybersecurity standards provided an opportunity for regulatory alignment. Improvements in automation and observability have been achieved, but further work is needed to address issues of interoperability and more widespread clinical validation.
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