Great engineers develop fascinating, life-changing medical technology. With great respect, almost with reverence, one admires the rapid progress of ever new technical possibilities and of meaningful changes. So far, so fantastic. But which (software) means justifies which end must be determined in the individual work with it.
On the way to product approval and market launch, we take all the hurdles of the manifold legal regulations, product requirements and, last but not least, business flanks such as scope, time and budget. To ensure that these do not become fun killers, beneficial software tools are used in project management, document management and requirements management.
Our project teams report from their practical experience:
Project management – plan, control, execute
We start with probably the best-known tool for project management: MS Project from Microsoft. It offers the possibility to plan projects in detail, to calculate the expected costs and required resources and to create offers on this basis. The planned milestones can then be tracked at any time during the course of the project and the time frame can be easily updated in the event of changes. The project manager can quickly obtain an overview of the status of the achievement of the project goals and possible deviations at any time.
In conjunction with MS Project, the use of JIRA from Atlassian is a good option. This tool, which is also very well suited for operational project management, can be used for software development as well as in other areas for various management tasks. For example, problem reports can be recorded, managed and tracked. In conjunction with MS Project, work packages can be created, distributed and their completion monitored. Even working time can be recorded via the tool.
Requirements management – efficient and error-free development
In the area of requirements management, on the other hand, we rely on Polarion ALM from Siemens in conjunction with the MedPack software from the provider Medsoto, which was specially developed for the medical technology industry. This tool for product and software development, which also takes into account the requirements of IEC 62304, makes it possible to map and track all areas of the V-model, from stakeholder and product requirements to risk mitigation requirements and design requirements. The beauty of this is that requirements management is not purely software-bound and can therefore very easily extend requirements management to the system, architecture and design levels respectively, thus mapping hardware and software in a continuous, traceable medical engineering documentation.
In addition, it offers the possibility of managing test specifications and associated test runs.
The Enterprise Architect tool from SparxSystems is ideal for software modeling; it can also be connected to JIRA via EA Xonnector. We use this tool in particular to create SysML models, across all disciplines. In addition, Enterprise Architect includes the ability to create static and dynamic views of the system.
In order to achieve the best possible quality of our device software, we use the TeamCity software from the supplier JetBrains according to the principle of continuous integration. This allows both software and firmware to be created in a defined environment and subsequent tests and reports to be generated. This enables good reproducibility, from which both our developers and our customers benefit.
To ensure our quality requirements according to EN ISO 13485, we use the process management software viflow from ViCon GmbH. This allows us to map all quality-relevant processes within the scope of our activities as a service provider for the medical device industry and make them centrally accessible to all employees. If required, other process standards such as EN ISO 14971, EN 62366-1 or the requirements of the MDR can also be mapped in an “audit-proof” manner. There are hardly any limits to a holistic approach to process modeling.
Do you have the right software in place?
The tools described form the core of the software tools we use. If we have aroused your interest in wanting to implement one of these applications yourself or to use it as part of a project with us, we will be happy to help you with the implementation. Since the spectrum of available software tools for project management, document management, requirements management and other relevant areas is much wider and always a question of the respective company structure, you can also contact us at any time about other software applications. We will be happy to advise you in the area of implementation, computer system validation and process modeling.
Links to the mentioned software:
MS Project: https://products.office.com/de-de/project/project-and-portfolio-management-software
JIRA: en.atlassian.com/software/jira
Polarion ALM: polarion.plm.automation.siemens.com/products/polarion-alm
MedPack: www.medsoto.de/unsere-produkte-leistungen-2/medpack
Enterprise Architect: www.sparxsystems.de/uml/neweditions/
Team City: www.jetbrains.com/teamcity/
ViFLow: www.viflow.de/de/
Please note that all data and listings do not claim to be complete, are without guarantee and are for information purposes only.
