IMT Leverages Helix ALM to Centralize Requirements Management and Reduce Risk
Consistency is key for engineering services provider IMT Information Management Technology AG of Switzerland (IMT). IMT works with several vendors across their medical device development process, and needed a way to ensure critical specifications were consistently up to date. They found the synchronization they needed in Helix ALM (formerly TestTrack).
They also discovered Helix ALM’s strong traceability features, which help IMT meet another big challenge of medical device development — complying with stringent worldwide international standards, such as ISO 13485 and FDA regulations.
Why Helix ALM?
Easy synchronization and sharing documents and work items
Strong risk analysis and management features
Automatic traceability of entire development process
Centralized requirements management
Automated compliance management and reporting
“We chose Helix ALM because it provided excellent performance for the price. We particularly value features such as the ease by which documents can be synchronized, the ability to share work items across documents, and simple interfaces for customers.”
Information Management Technology AG is a pure engineering service provider, focused on developing products and technology for the medical device industry. With a staff of 100 employees, IMT specializes in devices with software driven optical, electronic, and pneumatic structures, and components. The components IMT designs are used in the medical technology and industrial devices and modules.
Core Pain Points
IMT sought an integrated, affordable solution to manage and track requirements, risks, and testing primarily for their medical device products. The solution needed to meet certain criteria:
- It had to fulfill the IEC 60601-1 and IEC 62304 software standard, as well as similar standards and regulations from agencies around the world.
- It needed strong traceability that covered all software development work items, and allowed for reliable risk management.
- The risk management features needed to be strong enough for safety-critical medical devices, in accordance with IEC 14971.
- It had to provide complete traceability of all software development work items.
- The test management capabilities needed to provide the depth of coverage necessary for a high level of quality and safety.
After evaluating several solutions, IMT chose Helix ALM.
IMT’s development team loves Helix ALM because it was an affordable solution that provided all the features and capabilities they were looking for. On top of that, they discovered that with Helix ALM, they could:
- Create and maintain requirements documents easily, even when working with other companies.
- Clearly communicate and share work with long-distance customers.
- Share work items across documents to maintain consistency.
Strong, End-to-End Traceability
Because IMT develops medical devices and other safety-critical products, traceability is a key concern. Not only do they require strong traceability in order to prove regulatory compliance, but they also need it for managing risk and verifying that risk control measures have been tested.
Helix ALM automates traceability from the very beginning of IMT's development workflow. Features, tasks, test cases, and other development artifacts are automatically linked to the requirement or other development artifact from which they are created.
Automated traceability also helps IMT link risk control measures to the results of the tests of those measures. Benno Bieri, Business Development Manager and Senior Project Manager for IMT, said that risk to patients and operators is the primary concern. Bieri’s team also identifies and tracks control measures for other kinds of risks, he said, such as “radiation emission, physical damage, explosion, fire, that kind of thing.”
Because of Helix ALM’s traceability features, IMT is better able to prove compliance with several risk management and quality regulations — including ISO 62304, which covers the development of medical software and software within medical devices.
Streamlined Communication and Collaboration
Bieri found Helix ALM’s ability to share work items across documents particularly powerful. Because IMT works closely with manufacturing partners, projects often involve many different specifications that need to be shared with those companies as input for their delivery.
Thanks to Helix ALM’s ability to link related items, these specifications stay consistent across the entire project.
“If you change something in one place, it’s automatically changed in all the others,” Bieri said. “With many other tools, you can’t do that.” You have to manually maintain copies of the data, he added, and that gets out of hand over the project’s lifespan. “It’s very hard to make sure the data stays consistent over two or three years. So that’s a big advantage Helix ALM gives us.”
Helix ALM boosts IMT’s collaboration with customers, as well. As a service provider, Bieri’s team often gets ideas and unfinished requirements from customers. “Our job is to make that watertight, and that typically involves a lot of work that you have to do with the customer.”
Helix ALM allows all stakeholders — IMT’s and the customer’s — to participate in the requirements review process and see each other’s comments in real-time. When necessary, Bieri can even export requirements documents to Microsoft Word for customers, vendors, and stakeholders who do not have access to Helix ALM.
Helix ALM makes communication and collaboration with customers so easy, Bieri said, even if they’re located in another city or country.
Helix ALM gives IMT’s development teams the power to link all items for strong traceability, and to keep all work items automatically updated when a linked item is changed. They know they are always working from the most current document, without the risk of errors due to improper synchronization.
The ability to share items across levels and documents saves time and fosters consistency, which in turn boosts product quality.
Thanks to Helix ALM, IMT transparently collaborates with their customers to produce high-quality, safe, and compliant devices for the medical device industry.
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