The medical device software industry is increasingly subject to regulations; organizations are increasing their use of software management tools to define a rigorous process for risk and quality software management. It’s the better way to ensure standards compliance during both on-site and remote audits. Thus, choosing the appropriate software tool to implement strict comprehensive processes definitely makes it easier to apply best practices throughout the entire lifecycle of the software of your medical device. Tuleap is an ALM that helps organizations achieve this challenge. Here’s how it can also help you achieve your compliance challenges and meet the requirements of the IEC 62304 standard for your medical devices.


Why implementing Tuleap to achieve industry-standards compliance?

A tool like Tuleap can be a true ally when developing medical software products, as it helps:

  • Centralizing and securing all software projects’ data in one place, hence relying on a unique digital reference,
  • Having a large set of adapted tools for the integrated management of your medical device software’s development and maintenance processes (requirement management, risk management, release planning, version management, tests management, bug fixing, integrations…),
  • Standardizing processes thanks to templates (workspaces) that can be easily customizable accordingly to the specificities of both the organization and the industry,
  • Automatizing workflows to increase productivity and avoid risk occurrence in the artifacts and documents management process,
  • Ensuring automatic, end-to-end traceability throughout the whole software lifecycle via a thorough modification history,
  • Following activities and projects progress in real time via customizable (agile) dashboards that help prepare and pass compliance audits faster and more efficientlyeven remotely.

What is important to underline is that the tool comes to support, and not substitute, the organization because they both are necessary and actually complementary. The main point is to have a tool providing all the necessary features for software development management and maintenance – aka a good application lifecycle management tool (ALM).

The common medical device software lifecycle and how Tuleap helps at every stage

1. Use case definition

It is extremely important to have a clear insight into the software project’s scope and direction from the very beginning in order to ensure its smooth development and delivery, all the more within a highly-standardized industry such as the medical device. This is why it is primordial to understand customers’ needs.

Tuleap provides a workspace to collect customers’ expectations and needs, also called user stories, to subsequently ease the organization of all the technical tasks for the development of the desired features.

In addition to it, Tuleap provides teams with a secured document management workspace to store all their project information as well as to collaborate on documents.

tuleap document management
Tuleap interface: document management for medical device software projects

2. Analysis and risk management

Tuleap makes it possible to go further in risk management thanks to a notification system and mitigating risk management that can be defined accordingly to the product specifications and requirements. It’s even possible to add as many mitigating measures as you wish: for instance, if a new risk is generated when adding a new feature, it will be necessary to define a new mitigating risk measure that, in turn, will lead to another requirement to be met; and to complete the loop, this new requirement will suppose the creation of a new feature. All these elements can be easily set up via the central part of the Tuleap workspace interface, displaying a specific dashboard for Risk Management.

Now, how to integrate a new feature – such as a customer change request – once the development process got started? You can add it directly from the dashboard mentioned above, which is generally a Kanban board, and easily configure it: you can define/set/indicate/precise who will be working on it, its consequences on the medical device development, potential risk evolutions and, as a consequence, new additional mitigating risk measures to be considered, that are likely to have an impact on the ongoing development of other features.

Lastly, Tuleap allows linking any items among them via a parent-child hierarchy and then putting them into a customizable tracking system, ensuring seamless end-to-end traceability throughout the whole software project.

NOTE

A quick note about the different kinds of features: either it is directly based on a customer need, or it is generated from requirements during this analysis phase.

tuleap dependencies graph
Tuleap Dependency Graph: hierarchy among the different project artifacts related to the requirement “354086”

3. Planning

Once features are defined, teams can move on to the release planning phase, prioritizing work based on the requirements to be met. With Tuleap, the process corresponds to creating and organizing tasks (and even sub-tasks) via agile dashboards (i.e. Kanban boards). This enables teams to optimize their productivity thanks to increased visibility of the real-time progress of the development project. With the Agile Roadmap plugin, clearly show all the planned and/or ongoing releases, as well as the links and dependencies among them.

With the Agile Roadmap plugin, clearly show all the planned and/or ongoing releases, as well as the links and dependencies among them.

In other words, it is possible to:

  • outline a way more detailed development plan,
  • specify a starting date (and potentially an end date too),
  • define the costs in terms of effort, the « who does what »
  • and so on!
software project management for medical device

4. Development

Tuleap has several modules to improve teams’ efficiency and project management throughout the whole development phase: version management at scale, simplified code review, task automation via the API REST and webhooks… so, without ever leaving the Tuleap interface, you have everything you need to develop your medical device software products in one single tool.

Let’s take a look at Git version management, for example. You can find it in the menu bar on the left (see screenshot). There, you can easily create as many Git repositories as you wish and then set an automatic workflow for code review and continuous integration via Tuleap Pull Request. In addition to Git and Pull Request, Tuleap is a flexible software tool that can be seamlessly connected to other tools such as Jenkins, Gerrit and GitLab to go even further in continuous development and integration (CD/CI).

Here are some useful resources to get more details on other possible integrations with Tuleap and how to set them up:

5. Validation and maintenance

Tuleap also encompasses a module fully dedicated to test management. In fact, Tuleap Test Management® (TTM) helps you execute both automatic and manual tests as well as manage requirements within an integrated environment, this way avoiding struggling to pass from one tool to another.

You can execute many types of tests and set up your validation campaigns based on your needs: for instance, features tests to verify their smooth functioning and/or cross-case requirements tests to make sure that all the requirements involved comply with what has been previously defined. Also, with TTM it is possible to directly create an issue for which a quick bug fixing is needed; in turn, sometimes it can also lead to a new requirement to be integrated, re-verified, and hence tested via another validation campaign.

tuleap dependencies graph among requirements
test campaign management and software validation

NOTE

Proving to auditors the quality of your software and your IEC 62304 standard compliance has never been so easy: in a few clicks, get and visualize the full history of your development project thanks to a dynamic chart (see Tuleap dependency graph), showing how requirements, tests and any other artifact of the delivered product are linked among them.

customer success story

How does Sleepinnov Technology ensure its compliance to ISO 13485 and IEC 62304 standards for medical device software with Tuleap?