Mobile medical app development with a focus on traceability

Abstract

Today, the growth of medical devices and mobile medical applications is increasing enormously, thanks to the efficiency and enhancement of new technology. When it comes to mobile medical apps, developers need to understand what is required when a mobile application fulfils the definition of a medical device. Such applications have to be developed in compliance with medical device regulations. This can be a challenge for mobile medical application developers, as medical device software is normally developed in a manner that will also ensure the production of regulatory documentation that is essential to market such devices. In this paper, we identify the need for a mobile medical application development framework, the key criteria for such a framework, and describe how the results were collected through performing a Medical Device Software Development workshop. Furthermore, we describe how MDevSPICE together with an agile software development approach can be tailored to support a mobile medical applications development framework. We detail one of the key criteria for mobile medical application development framework—traceability.

Development and assessment of blockchain‐IoT‐based traceability system for frozen aquatic product

“…It specifically concludes in Table 3, which shows it can satisfy the requirements of practical tracing functions. The efficiency of data on‐chain operations and tracing queries are the important assessments for this platform (Trektere et al, 2017).…”

“…It specifically concludes in Table 3, which shows it can satisfy the requirements of practical tracing functions. The efficiency of data onchain operations and tracing queries are the important assessments for this platform (Trektere et al, 2017). The left part in Figure 11 shows that the average time cost of tracking data upload is influenced by the frequency of on-chain requests and data size.…”

“…Nowadays, the prevailing monitoring and tracking application of the Internet of things (IoT) significantly improve the supervision efficiency for the aquatic supply chain industry and adds enormous value to that field (Alfian et al, 2020; Badia‐Melis, Mc Carthy, Ruiz‐Garcia, Garcia‐Hierro, & Robla Villalba, 2018; Feng, Chen, Zhou, Rungsardthong, & Zhang, 2019; Košťál, Helebrandt, Belluš, Ries, & Kotuliak, 2019; Peng et al, 2018; Pigini & Conti, 2017; Trektere et al, 2017; Vivaldi et al, 2020). The traceability system mainly relies on the quality and safety data reported by the aquaculture and circulation enterprises themselves, and the data is uploaded to the supervision department, and consumers can query the concerned food quality information through the traceability platform (Bhatt et al, 2016; Gooch, Dent, Sylvia, & Cusack, 2017; Xinqing, Fu, Yongjun, Zhaohui, & Zhang, 2017).…”

Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health

“…Moreover, approaches to classifying software and applications with respect to risk classes J 2021, 4 were shown [6]. Trektere et al [8,9] pointed out the necessity for an mHealth application development framework and its key criteria. They presented an existing framework for medical device software development and an approach to how it can be tailored for use in the context of mHealth application development.…”

“…They presented an existing framework for medical device software development and an approach to how it can be tailored for use in the context of mHealth application development. In [9], the author drew particular attention toward the key criteria Traceability, which is essential in the development process to ensure reliable software [9].…”