codeBeamer in practice – successful software development for medical devices

‘When regulations and the ALM tool codeBeamer suddenly resemble your partner’ – as a Requirements Engineer (RE) in an agile software development project for a medical device, they were my trusted partners. And I can tell you: Without codeBeamer, I would have had less fun with requirements engineering! Have you ever wondered how a single tool can make all the difference? In this blog post, I will show you how this tool has made my daily work easier and what lessons learned and best practices have been derived from it. You heard right: codeBeamer has transformed my work and increased my enthusiasm for requirements engineering! First, I will take a look at the term Application Lifecycle Management (ALM) and explain why precise requirements engineering in medical technology is crucial for the safety of medical devices.

An ALM tool: a guarantee for transparency and traceability

As a comprehensive application lifecycle management solution, codeBeamer from PTC provides a central platform for the collaborative development, management and optimisation of complex technologies and products. In medical technology, where various regulations such as the European Medical Device Regulation (MDR), ISO 13485 (quality management for medical devices), ISO 14971 (risk management for medical devices), IEC 62304 (software life cycle process for medical devices), IEC 62366-1 (usability for medical devices) and IEC 81001-5-1 (health software and health IT systems security) to name a few, traceability and clean documentation of regulatory artefacts are essential. An ALM tool not only ensures transparency here, but also transforms the documentation process into a kind of ‘audit superhero tool’. Who doesn't want documentation that shines during audits?

Requirements engineering: a key to safety in medical software development

There is no room for error in software development for medical devices – and that's a good thing! Requirements must be clearly defined, documented and seamlessly tracked – a tiny mistake can have serious consequences for users. This is where requirements engineering comes into play, the essence of every successful software development for medical devices. Want to learn more about it? Then be sure to check out my colleague Phuong Khanh Höfle-Nguyen's blog post on the topic of ‘RE for medical devices and in medical technology’. In the field of requirements engineering for medical devices, where precision is crucial, an ALM tool like codeBeamer is an indispensable partner – one that works collaboratively, transparently and efficiently!

Regulatory requirements of IEC 62304: optimally integrated in codeBeamer

Software development for medical devices is subject to strict regulations, in particular the IEC 62304 standard. This standard defines how to develop safe and high-quality software for medical devices and defines the necessary processes for development, maintenance and management, including risk analysis and documentation.

As part of the Software Development Plan (SDP) required by the standard, we integrated and documented our development process in codeBeamer. We were also able to individually configure our project-specific workflows at any time with just a few clicks, enabling us to work in an agile manner despite strict regulations. Contradiction? More like a well-choreographed dance! With codeBeamer, we moved safely and agilely through the compliance jungle.

With a single tool, we were able to map a clearly structured and agile development process while also managing regulatory requirements centrally and transparently at all times:

• Exact requirements definition: Clear, comprehensible requirements formed the basis.
• Design and implementation: Each phase was documented and linked to requirements.
• Verification and validation: Each requirement was checked, each test case documented.

A lack of traceability? Then an audit can quickly become critical! This is exactly where codeBeamer showed its strengths. With this tool, we can not only manage requirements, risks and test cases centrally, but also link them automatically, ensuring that every change remains fully traceable via the ‘history function’ – ideal for regulated industries that are subject to regulatory requirements and where audits are an ongoing part of the agenda.

Requirements engineering with codeBeamer: effective requirements management made easy

Manage requirements – with enthusiasm to success!

In our project, codeBeamer proved to be an invaluable tool that offers much more than just a central repository for requirements. It enabled a clear structure for the entire development process and ensured that nothing was lost – from the initial idea to the final test. As the requirements engineer, I was responsible for ensuring that the user stories (the smallest unit in the requirements management process in the project) were always reliably and audit-ready linked to the numerous higher-level software and system requirements and, if necessary, only changed in one central location. With codeBeamer, the initial Herculean task quickly became a relaxing meditation exercise – everything in one place, everything in view and perfectly structured with self-configured reports and boards.

codeBeamer as a decisive factor:

• Central platform: All requirements, designs, test cases and documents were recorded and versioned centrally. Each release could be effortlessly and automatically documented using the baseline function.
• Automatic traceability: The linking of requirements with test cases, risks or (technical) designs was automatic – fully documented and accessible at any time.
• Simple change management: New or changed requirements? No problem! codeBeamer documented every change or adjustment and immediately showed the effects.

It was amazing how often a single term was all it took to quickly find a requirement months or years back. No more endless documents or scattered tools – codeBeamer's search function made everything possible. Almost like having a personal assistant who never needs coffee.

Requirements and test cases – the perfect dream team!

A key feature of codeBeamer is the ability to link requirements directly to test cases, creating the perfect pair where the link is instantly recognisable at a glance. This meant that we could always see whether a requirement had been fully implemented and successfully tested. This ensured a high level of quality control, as each requirement was covered by a corresponding test case – minimising the risk of errors and ensuring the quality of the software.

codeBeamer as a decisive factor:

• Test management: Parallel test management efficiently checked the functionality, security and performance of the software. Based on the status and risk assessment of the requirements, the test team could immediately see whether a (new) test case was needed and when it had to be finally created.
• Defect management and reporting: If a test case failed, we could immediately identify the affected requirement and take targeted action. This allowed us to create bug tickets directly from the test run with just a few clicks and export them as reports.
• Quality assurance: No requirement was overlooked thanks to the traceability function. Everything was tested and documented to meet strict medical regulations.

Close collaboration between the requirements engineer and test manager in codeBeamer was key to meeting the requirements exactly while ensuring the highest software quality. And the best part? A strong team working hand in hand! With teamwork, good humour and a clear vision, we mastered the complex requirements – and never lost sight of the fun.

Collaboration with the customer – transparency builds trust!

Another advantage of codeBeamer was the improved collaboration with our customer. The central platform allowed the customer to view the project progress at any time – like a VIP guest with access to the players' dressing room at a UEFA Champions League game. This meant that all stakeholders were always up to date and could monitor the project goals together.

codeBeamer as a decisive factor:

• Collaboration: The customer and the project team were able to create, review and approve requirements together.
• Transparency: The customer was able to see the status of requirements, development and testing at all times.
• Prioritisation: Together, we were able to decide which requirements were most important and prioritise them accordingly.

This created trust and significantly simplified the decision-making processes. No more annoying back-and-forth emails – all the information was always up to date and at hand.

Requirements engineering meets project management – Together for the optimal tool configuration!

codeBeamer is like a Swiss army knife for requirements engineering – it has many useful features, but it doesn't magically pull solutions out of thin air or solve all the challenges that can arise in project management. Therefore, good project management is essential to effectively manage the various aspects of a project. CodeBeamer must also be configured correctly before use to fit the project. The right mix of tool configuration and management is the cherry on top, enabling you to meet the challenges of requirements engineering. My experience: Coordinate with your project management and the project team and adapt the tool to your jointly defined project goal and your individual requirements for the project roles. This creates a clear focus that improves the project's results – project success is teamwork!

From scepticism to enthusiasm – why codeBeamer is convincing!

When I started the project in November 2020, I was sceptical about codeBeamer because the multitude of functions and possibilities seemed quite overwhelming. But the more I explored it, the more I discovered how intuitive the tool is. Working closely together as a team is particularly important to me – codeBeamer encouraged this because we all ‘lived’ the tool in the project! Over time, I became a real fan of codeBeamer. It has revolutionised the way I work in requirements engineering – managing complex requirements efficiently, always with quality and complete documentation. The structure and security it brings not only makes the whole thing easier, but also much more enjoyable.

What happens when a requirements engineer uses codeBeamer? Here are the answers – short and sweet:

Best Practices: Tips for getting started

Do you want to try out the tool yourself? No problem! A 30-day free trial of codeBeamer can be downloaded and tested from the PTC homepage.

To get off to a successful start with codeBeamer, it is recommended that you begin with targeted training and workshops to familiarise your teams with the tool's functions. Both PTC and adesso offer tailored training and education to get you started with codeBeamer quickly and efficiently.

Did you know that adesso is listed as an official codeBeamer implementation partner at PTC? adesso offers advice and support when introducing codeBeamer. Our experienced experts work with the tool on a regular basis and are therefore very familiar with it. To exploit the full potential of codeBeamer, existing processes must be analysed and optimised – each project requires an individual and customised solution. We help you to configure the tool specifically for the requirements of a project or industry.

Conclusion: codeBeamer is a success across industries

In my experience, codeBeamer enables clear structures, traceability and efficient collaboration within the project team. The tool is indispensable, especially in regulated projects in the field of medical technology, where documentation, traceability and audits are crucial. If you are now thinking ‘I understand the potential and advantages of codeBeamer, but I don't work in medical technology!’ I can reassure you: codeBeamer's versatile skills are not limited to medical technology. The tool can also be used to full effect in other industries, such as the automotive, aerospace and energy sectors. Wherever precise requirements engineering and seamless documentation are required, codeBeamer ensures the necessary structure and efficiency. With codeBeamer, every project – in every industry – can be a strategically managed success!