How Andreas Hettich GmbH & Co. KG Achieved MDR and IDR Compliance Through the Traceability of Helix ALM
As a mid-sized team specializing in embedding desktop software for centrifuges and incubators, utilizing a planning and tracking tool that has precise and automated traceability is crucial for the Germany-based Andreas Hettich GmbH & Co. KG. The devices that they produce are subject to stringent medical device and in vitro device regulations. Achieving compliance with these regulations and passing through auditing in a timely manner is integral for Hettich Lab to get their products to market.
Thanks to the world-class traceability in Helix ALM, and the advanced configurability to create a complex workflow, Hettich has been able to save a considerable amount of time and resources by easily demonstrating their adherence to regulations and achieve compliance.
Why Andreas Hettich GmbH & Co. KG Loves Using Helix ALM
Achieved MDR and IDR Compliance
Quickly Passed Through Auditing
Built a Unique and Complex Workflow
The Power of Helix ALM’s Workflow Engine
Konstantin Koshel joined Hettich in 2018 as a Software Engineer and now serves as the Head of Software Development. One of Konstantin’s favorite elements of Helix ALM is how configurable the workflow engine is.
“The workflow that I have implemented in our organization is quite complex,” Konstantin says. “I was able to partner with the Helix ALM support team to create a reliable workflow.”
Everything within the Helix ALM workflow engine can be uniquely configured, which has enabled Konstantin to create a complex workflow that guides his team members through their development tasks, ensuring that all of the relevant regulation and compliance standards are followed. With a more basic tool, Konstantin would not be able to implement the strict complexity of his workflows, which would open up the possibility for a team member to miss a compliance standard.
“Again, because of the complex workflow I’ve created within ALM, it’s impossible for my team to accidentally miss a regulation or compliance standard. They are guided step-by-step to the finished product.”
Superior End-to-End Traceability with Helix ALM
By utilizing the workflow engine of Helix ALM, Hettich Labs has been able to achieve compliance with the medical device regulations they face. Konstantin attributes that to the control he has over the creation of his workflows and the ease of creating traceability reports. The end-to-end traceability reports of Helix ALM were extremely helpful during a recent audit.
“With Helix ALM, I am able to create distinct link sets that follow particular rules. With other tools, I did not have the possibility of creating different link sets. This was quite useful during our most recent audit.”
This is critical for Hettich, as the scope of MDR compliance includes monitoring device performance, detecting potential safety issues, and benefit-risk assessments.
Hettich was able to provide system access to the auditors, which streamlined the auditing process. Requirements, risk management, bug tracking, testing -- everything in the lifecycle is automatically documented in the traceability reports within Helix ALM.
As organizations in the medical device industry know well, the faster a product can achieve compliance or pass through an audit, the more time and resources a team will have to focus on the development of new products.
Working with the ALM Support Staff
Konstantin and his team are thrilled with where their workflow is at today, but they know that changes will be required over time. Over the years, Konstantin has tweaked their workflow to accommodate for changes in compliance standards, as well as to allow for new features and functionality that come with Helix ALM software updates. In both cases, he partners with the Perforce Support Team.
Konstantin has been very pleased with his interactions with the Perforce support team. For every challenge he has faced, he and the support team have been able to configure the tool to solve their unique challenges.
Hettich is an industry-leading manufacturer of centrifuges and incubators based in Tuttlingen, Germany. Their state-of-the-art products are used by companies across the globe.
Lowering Product Development Cycle Time
Ensuring Product Quality
Medical Device Regulation
Invitro Device Regulation
Creating a Complex Workflow to Ensure Compliance
Helix ALM from Perforce