TNI Medical sees 50% rise in productivity with Matrix Requirements

Meeting demanding quality standards

TNI Medical concentrates on the treatment of spontaneously breathing patients of all age groups who would benefit from a supply of heated and humidified respiratory gases with high flow.

Xenija Huebner, Quality Assurance Specialist at TNI Medical AG, handles hundreds of quality management projects and processes, along with compliance with ISO 13485 and MDSAP standards.

“Maintaining quality and controlling risk present a time-consuming, ever-present workload,” says Huebner. “At the time I joined, we were using essentially a detailed folder structure to store, manage, and update our quality documentation and processes. Our management system relied on manual intervention, and in some cases physical storage of signed paperwork. For example, to incorporate a change, we would locate and update all the affected documents, and retain dated copies to provide traceability.”

Manual systems and systematic gaps

Using manual records on paper and spreadsheets, the team found it difficult to keep track of all the Word documents and templates that defined processes. Each change and authorization would be managed manually, trawling through project folders to ensure all instances were correctly updated. Existing record-keeping and process-tracking systems were time-consuming to operate, and the team found it challenging to cover systematic gaps efficiently.

“When we released new processes, we would invite staff to a meeting—but we had to manually track all the affected departments and the training schedules for the related changes,” continues Huebner.

The TNI Medical AG quality assurance team realized that its in-house routines were not fully effective in capturing process dependencies, which could delay identifying business risks, perhaps by impacting production or affecting standards compliance.

“Our risk assessments were time-consuming and complex,” reports Huebner. “We wanted to streamline our quality management processes, understand our business risks, and greatly improve traceability. If we could resolve these issues, we could considerably accelerate development and production.” 

Selecting an agile solution

TNI Medical AG was already using MatrixALM to manage requirements for its medical device development. Based on the positive experience of increased productivity powered by MatrixALM, the team was naturally curious to learn more about MatrixQMS. As a quality management solution designed specifically for medical device manufacturers, MatrixQMS provides support for ISO 13485, ISO 27001, and ISO 9001.

“Right away, we saw how MatrixQMS could transform our approach to quality management,” says Huebner. “Using MatrixQMS, we can define every single process, instructions for building new processes, and retain full auditability and traceability of our actions.”

Within three months, TNI Medical AG switched to the MatrixQMS solution, converting paper to digital records.

“Initially, some of the team was skeptical of the change, as we had become very familiar with our traditional methods,” says Huebner. “Now, with MatrixQMS, we find people really enjoy their work, as we have removed tedious administration and enabled them to focus on quality management itself. Even the most reluctant users are natural converts!” 

Driving rapid adoption, saving time

Users have rapidly adopted MatrixQMS, greatly streamlining the team workflow. Time previously spent on physical paperwork or waiting for a signed approval has been eliminated with electronic records and authentication.

“With yearly audits for standards compliance, MatrixQMS is essential. We use the templates to generate efficient forms—seamlessly streamlined when compared with our original text documents—that we sign electronically and archive automatically,” says Huebner. “It’s difficult to overstate just how big an advantage it is to have full traceability of every action for change management, history, and approval.” 

Unlocking major productivity improvements

By replacing manual working with MatrixQMS, TNI Medical AG is experiencing remarkable productivity improvements that help to drive company success.

“We estimate that MatrixQMS helps us achieve approximately 60% more-efficient quality management processes,” explains Huebner. “We save up to 15 hours formerly spent on quality management administration, such as hunting for files or confirming qualifications. We estimate that the team is 50% more productive, handling more projects without increasing headcount.”

TNI Medical AG continues to innovate its high flow and related technologies, with sophisticated new devices under constant development. Huebner concludes, “With both MatrixALM and MatrixQMS, TNI Medical AG can ensure that both requirements management and quality standards are as efficient as possible, and we are fully empowered to deliver our new products to market on time, on budget.”