YOUR SELEON SPECIALIST

Patrick Blumentritt
Head of Consulting North,
Quality Management & Regulatory Affairs

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

 

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14.02.2019

Projects, Documents and Requirements in Medical Technology: Practice-proven Software.

Nothing works without software in the planning, control and implementation of medical technology projects. Tools are needed to develop efficiently and with minimal errors. But which tools are suited best?

[Inhalt: Englisch] anforderungsmanagement-software-medizintechnik

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 meaningful changes. So fantastic so far. But which software-tool serves which purpose, has to be proven in the individual work with it.

On the way to product approval and market launch, we overcome all the challenges posed by the manifold legal regulations, product requirements and, last but not least, economic constraints such as scope, time and budget. So that all these do not become the fun killers, beneficial software tools are used for project management, document management and requirements management.

Our project teams report on tools from their own 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 quotations on this basis. The planned milestones can then be tracked at any time during the course of the project and the timeframe can be easily updated in the event of changes. The project manager gets a quick overview of the status of achievement of the project goals and possible deviations at any time.

In association with MS Project the use of JIRA from Atlassian is recommended. This tool, which is also very suitable for operational project management, can be used both for software development and 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 processing monitored. Even the working time can be recorded by using this tool.

 

Requirements Management - efficient and low-error development

In the area of requirements management, however, we rely on Polarion ALM from Siemens in conjunction with MedPack software from Medsoto, which has been specially developed for the medical technology industry. This product and software development tool, 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 great thing about it is that requirements management is not purely software-bound and can therefore very easily extend requirements management to the system, architecture and design levels, thus mapping hardware and software in a consistent, traceable medical engineering documentation.

It also provides the ability to manage test specifications and their associated test sessions.

The Enterprise Architect tool from SparxSystems is ideal for software modeling; it can also be linked to JIRA via EA Xonnector We use this tool in particular to create SysML models across all disciplines. Enterprise Architect also includes the ability to create static and dynamic views of the system.

In order to achieve the best possible quality of our device's software, we use the TeamCity software from JetBrains acting up to the principle of continuous integration. This allows both software and firmware to be designed in a defined environment and subsequent tests and reports to be generated. This enables a good reproducibility from which both our developers and our customers benefit.

To ensure our quality requirements in accordance with EN ISO 13485, we use the process management software viflow from ViCon GmbH. It enables us to map all quality-relevant processes within the framework 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 "audit-proof". There are hardly any limits to a holistic approach to process modeling.

 

Are you using the right software?

The above mentioned tools represent the core of the software tools we use. If we have awakened your interest to implement one of these applications yourself or to use it in the context 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 larger and always a question of the respective company structure, you can also contact us at any time about other software applications too. We are happy to advise you in the area of implementation, computer system validation and process modeling.

Links to the mentioned software:


Please note that the details and bullet points listed are not intended to be exhaustive, are supplied without liability and only serve as information

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

CONTACT YOUR SELEON SPECIALIST

[Inhalt: Englisch]

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