First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit

BACKGROUND: According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). METHODS: The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. RESULTS: The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. CONCLUSIONS: The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers

Animating the evolution of software

The use and development of open source software has increased significantly in the last decade. The high frequency of changes and releases across a distributed environment requires good project management tools in order to control the process adequately. However, even with these tools in place, the nature of the development and the fact that developers will often work on many other projects simultaneously, means that the developers are unlikely to have a clear picture of the current state of the project at any time. Furthermore, the poor documentation associated with many projects has a detrimental effect when encouraging new developers to contribute to the software. A typical version control repository contains a mine of information that is not always obvious and not easy to comprehend in its raw form. However, presenting this historical data in a suitable format by using software visualisation techniques allows the evolution of the software over a number of releases to be shown. This allows the changes that have been made to the software to be identified clearly, thus ensuring that the effect of those changes will also be emphasised. This then enables both managers and developers to gain a more detailed view of the current state of the project. The visualisation of evolving software introduces a number of new issues. This thesis investigates some of these issues in detail, and recommends a number of solutions in order to alleviate the problems that may otherwise arise. The solutions are then demonstrated in the definition of two new visualisations. These use historical data contained within version control repositories to show the evolution of the software at a number of levels of granularity. Additionally, animation is used as an integral part of both visualisations - not only to show the evolution by representing the progression of time, but also to highlight the changes that have occurred. Previously, the use of animation within software visualisation has been primarily restricted to small-scale, hand generated visualisations. However, this thesis shows the viability of using animation within software visualisation with automated visualisations on a large scale. In addition, evaluation of the visualisations has shown that they are suitable for showing the changes that have occurred in the software over a period of time, and subsequently how the software has evolved. These visualisations are therefore suitable for use by developers and managers involved with open source software. In addition, they also provide a basis for future research in evolutionary visualisations, software evolution and open source development

SIT automation tool: failure use case automation and diagnosis

Study of systems to manage the performance and quality of service of wireless data networks. Work with optimization techniques and project management to solve complex networks issues.The scope of this thesis is the SIT (System Integration Testing) process which is the testing procedure executed in customer test environment before the software goes on production environment. The main objective for this thesis is no other than improving the current process step by step taking into account the automation, efficiency, missing checks and much more. This project is a kind of Industrial process to create a powerful testing tool which can allow the company to deliver quality adaptor products efficiently, do better in less time helping to reduce costs, as Adaptors are the most demanded product of MYCOM OSI portfolio. Take into account that business is not only generated when an Adaptor is delivered for first time but also when Vendors provide with new releases and new functionalities and operators needs to order an upgrade of the Adaptor to be able to monitor the new functionalities deployed on their network.El campo de aplicación en el que está centrado esta tesis es el SIT (System Integration Testing), proceso de testeo ejecutado en un servidor de testeo del cliente antes de desplegar el software el medio de producción. El objetivo principal de esta tesis no es otro que mejorar el proceso actual paso a paso teniendo en cuenta la automatización, eficiencia, la falta de verificaciones, entre otros. Este proyecto es una especie de proceso industrial para crear una aplicación potente de testeo que pueda permitir a la compañía entregar adaptadores de calidad con eficiencia, que hagan más en menos tiempo ayudando así a reducir costes. Los adaptadores son el producto más demandado del porfolio de MYCOM OSI. Hay que tener en cuenta que el negocio no se genera solamente cuando se entrega por primera vez el adaptador al cliente, sino que cuando los proveedores lanzan nuevas versiones con nuevas funcionalidades y los operadores necesitan encargar una mejora del adaptador para poder monitorizar las nuevas funcionalidades desplegadas en su red.El camp d'aplicació en que es basa aquesta tesi és el SIT (System Integration Testing), procés de testeig executat en un servidor de testeig del client abans de desplegar el software al mitjà de producció. L'objectiu principal d'aquesta tesi no és un altre que millorar el procés actual pas a pas tenint en compte l'automatització, l'eficiència, la falta de verificacions, d'entre altres. Aquest projecte és una mena de procés industrial per crear una aplicació potent de testeig que pugui permetre a la companyia lliurar adaptadors de qualitat amb eficiència, que facin més en menys temps ajudant així a reduir costos. Els adaptadors són el producte més demandat del porfolio de MYCOM OSI. Cal tenir en compte que el negoci no només es genera quan es lliura per primera vegada l'adaptador al client, sinó que quan els proveïdors llancen noves versions amb noves funcionalitats i els operadors necessiten encarregar una millora de l'adaptador per poder monitoritzar les noves funcionalitats desplegades a la seva xarxa

Gateway Modeling and Simulation Plan

This plan institutes direction across the Gateway Program and the Element Projects to ensure that Cross Program M&S are produced in a manner that (1) generate the artifacts required for NASA-STD-7009 compliance, (2) ensures interoperability of M&S exchanged and integrated across the program and, (3) drives integrated development efforts to provide cross-domain integrated simulation of the Gateway elements, space environment, and operational scenarios. This direction is flowed down via contractual enforcement to prime contractors and includes both the GMS requirements specified in this plan and the NASASTD- 7009 derived requirements necessary for compliance. Grounding principles for management of Gateway Models and Simulations (M&S) are derived from the Columbia Accident Investigation Board (CAIB) report and the Diaz team report, A Renewed Commitment to Excellence. As an outcome of these reports, and in response to Action 4 of the Diaz team report, the NASA Standard for Models and Simulations, NASA-STD-7009 was developed. The standard establishes M&S requirements for development and use activities to ensure proper capture and communication of M&S pedigree and credibility information to Gateway program decision makers. Through the course of the Gateway program life cycle M&S will be heavily relied upon to conduct analysis, test products, support operations activities, enable informed decision making and ultimately to certify the Gateway with an acceptable level of risk to crew and mission. To reduce risk associated with M&S influenced decisions, this plan applies the NASA-STD-7009 requirements to produce the artifacts that support credibility assessments and ensure the information is communicated to program management

Definition, technology readiness, and development cost of the orbit transfer vehicle engine integrated control and health monitoring system elements

An Integrated Control and Health Monitoring (ICHM) system was conceived for use on a 20 Klb thrust baseline Orbit Transfer Vehicle (OTV) engine. Considered for space used, the ICHM was defined for reusability requirements for an OTV engine service free life of 20 missions, with 100 starts and a total engine operational time of 4 hours. Functions were derived by flowing down requirements from NASA guidelines, previous OTV engine or ICHM documents, and related contracts. The elements of an ICHM were identified and listed, and these elements were described in sufficient detail to allow estimation of their technology readiness levels. These elements were assessed in terms of technology readiness level, and supporting rationale for these assessments presented. The remaining cost for development of a minimal ICHM system to technology readiness level 6 was estimated. The estimates are within an accuracy range of minus/plus 20 percent. The cost estimates cover what is needed to prepare an ICHM system for use on a focussed testbed for an expander cycle engine, excluding support to the actual test firings