Towards RegOps : A DevOps Pipeline for Medical Device Software

The manufacture of medical devices is a strictly regulated domain in the European Union. Traditionally, medical software compliance activities have been considered manual, document-centric, and burdensome. At the same time, over the last decade, software companies have maintained competitiveness and improved by relying on essential practices of DevOps, such as process automation and delivery pipelines. However, applying the same principles in medical software can be challenging due to regulatory requirements. In this paper, we utilize a systematic approach to align the essential medical device software regulatory requirements from the standards IEC 62304 and IEC 82304-1 and integrate them into the software delivery pipeline, which is the main contribution of our work. The outcome supports practitioners to establish more efficient software delivery models while maintaining compliance with the medical device standards.acceptedVersionPeer reviewe

Implementation of a registry management component for mobile sampling service

The objective of this thesis was to implement a registry management component for a mobile sampling service at Mylab Oy. The company is a major manufacturer of healthcare information systems in Finland. The component is a part of a server implementation that is installed for customers around Finland. The service installed for the customer is administrated through the registry management component. The purpose of this thesis was to make administration of the mobile sampling service more intuitive, create a manageable device register and make it possible to expand the mobile service for future customers. The requirements set for the registry management component were the ability to control device access and administrate registries through web user interface. The component should be reliable and usable in production environment. The implementation consists of a JAX-RS RESTful web service and an AngularJS sin-gle-page application. The web service is implemented with technologies such as Jersey, EclipseLink MOXy and EclipseLink JPA. The single-page application is implemented with technologies such as AngularJS and Twitter Bootstrap. The implementation is packaged into a single install file ready to be deployed to a customer. The project met all the requirements given and was installed to the customer’s production environment in the autumn 2015. The implementation will be used by the registry administrators from within the company. The project gave valuable knowledge for the future development and experience for implementing the next iterations of the application.Opinnäytetyön tavoitteena oli toteuttaa rekisterinhallintakomponentti liikkuvaan näytteenottojärjestelmään Mylab Oy:lla. Yritys valmistaa laboratoriojärjestelmiä Suomessa. Komponentti on osa suurempaa palvelintoteutusta, joka asennetaan asiakkaille ympäri Suomea. Palvelintoteutusta hallinnoidaan rekisterinhallintakomponentin kautta. Opinnäytetyön tarkoituksena oli parantaa kykyä hallita mobiilipalvelua, luoda hallittava laiterekisteri ja tehdä mahdolliseksi laajentaa palvelua tuleville asiakkaille. Opinnäyte-työn toimeksiantona oli mahdollistaa laitteiden pääsynhallinta ja rekistereiden hallinta web-käyttöliittymän kautta. Komponentin on tarkoitus olla luotettava ja käytettävä tuotantoympäristössä. Toteutus koostuu JAX-RS-standardiin perustuvasta, REST-pohjaisesta, www-sovelluspalvelusta ja yhden sivun -arkkitehtuuriin perustuvasta web-sovelluksesta. Www-sovellus on toteutettu käyttäen tekniikoita Jersey, EclipseLink MOXy ja EclipseLink JPA. Web-sovellus on toteutettu käyttäen tekniikoita AngularJS ja Twitter Bootstrap. Toteutus on paketoitu yhdeksi asennuspaketiksi, joka voidaan asentaa suoraan asiakkaalle. Projekti täytti kaikki vaatimukset ja on asennettu asiakkaan tuotantoympäristöön syksyllä 2015. Tuotosta käyttää yrityksen sisällä toimivat rekisterin ylläpitäjät. Projekti antoi arvokasta tietoutta ohjelmistokehityksen metodeihin ja kokemusta seuraavien versioiden tuottamiseen palvelusta

Integration of EU medical device regulatory requirements into a CI/CD pipeline

Manufacture of medical device software is strictly controlled by the law in European Union region. The medical device regulations could be seen as cumbersome and difficult to incorporate into the manufacturing process of a software. The regulations introduce a rigid product life cycle process to medical device software products, which could be seen as counter-intuitive by the software industry. Meanwhile, the software industry has found DevOps culture and practices, such as process automation and delivery pipelines, which are utilized to improve the competitiveness and reliability of the software business. This thesis tries to find a common ground between the European Union medical device regulatory requirements and modern software development practices. The European Union medical device regulatory framework is introduced, followed by a systematic document analysis of the standards IEC 62304 and IEC 82304-1 to identify applicable requirements for a CI/CD pipeline. As a result, a reference model for regulated CI/CD pipeline is introduced. For practitioners, tools and activities were found, that could help to overcome some of the burdensome activities, required by the medical device regulations. Additionally, the benefits of integrating CI/CD pipeline into the medical device manufacturing process is examined, such as the possibility for early customer feedback. For researchers, a document analysis based on the standards IEC 62304 and IEC 82304-1 is provided. Moreover, the proposed regulated CI/CD pipeline model can be expanded to cover more regulatory requirements. Finally, research topics related to medical device software manufacturing are discussed