Affiliation:
1. Embedded Lab, Federal University of Campina Grande, Brazil
Abstract
Agile Software Development (ASD) can be considered the mainstream development method of choice worldwide. ASD are used due to features such as easy management and embrace of changes, where change in requirements should be taken as a positive feature. However, some domain verticals, such as medical-healthcare, are classified as critical-safety system, which usually requires traditional methods. This chapter presents a practical use case describing the evolution of a software product that was conceived as a wellness software for end-users in mobile platforms to a medical-healthcare product restricted to regulatory standard recommendations. It presents the challenges and how the ASD is compatible to standards such as ISO/IEC 82304-1.
Reference20 articles.
1. AAMI. (2012). TIR45:2012 - Guidance on the use of agile practices in the development of medical device software. Association for the Advancement of Medical Instrumentation, 21, 22-78.
2. Introducing Traceability Information Models in Connected Health Projects
3. Barbosa, P., Queiroz, J., Santos, D., Figueiredo, A., Leite, F., & Galdino, K. (2018, June). RE4CH: Requirements Engineering for Connected Health. In 2018 IEEE 31st International Symposium on Computer-Based Medical Systems (CBMS) (pp. 292-297). IEEE.
4. Unique device identification and traceability for medical software: A major challenge for manufacturers in an ever-evolving marketplace
5. Bluetooth, S. I. G. (2020). Bluetooth SIG specifications. Retrieved February 20, 2020, from https://www.bluetooth.com/specifications/