Bruxless Success Story

Offering relief from teeth-grinding

Bruxism—the involuntary grinding of the teeth, especially at night—is a health problem that affects an estimated 30% of the population. Teeth-grinding can cause a range of health problems, including dental fractures, periodontal disease, and even tooth loss.

Founded in 2021, Bruxless is developing a first-of-its-kind tool to treat bruxism. Using a groundbreaking medical device, the Bruxless solution detects bruxism and uses functional proprioceptive stimulation to stimulate and relax the patient’s jaw muscles, helping to prevent grinding and reduce the risk of damage to teeth. Using the Bruxless mobile app, patients can monitor episodes of bruxism and track the effectiveness of their treatment.

Targeting regulatory approval

Bruxless aims to bring its new product to market in Europe by 2025. To achieve a fast time to market, the company is focused on attaining regulatory approval for its solution, beginning with clinical authorization to conduct initial medical trials from its notified body in France.

Johanna Mimouni, Quality Assurance and Regulatory Affairs Manager at Bruxless, says: “Our new product comprises multiple hardware and software components, each of which must be developed in accordance with stringent quality standards. To ensure the safety and efficacy of our product, we must manage approximately 250 requirements. With a lean team of eight full-time employees, we realized that it would be prohibitively complex and time-consuming to handle traceability analysis manually.”

Bruxless also recognized that building its quality management system (QMS) by hand would consume  significant time and resources.

Guillaume Cristovao, Team and Technical QA Lead at Bruxless, confirms: “It was extremely difficult to keep our QMS documentation up to date using spreadsheets and text documents. So, we looked for a way to automate this process in line with ISO 13485 and ISO 27001.”

Selecting an end-to-end solution

After reviewing offerings from several market leaders in requirements and quality management, Bruxless selected MatrixALM and MatrixQMS. End-to-end solutions designed by medical device experts, MatrixALM and MatrixQMS enable Bruxless to effectively manage technical documents, test cases, and risks, and adopt a proactive, risk-based approach to quality management.

Johanna explains: “From the very beginning, we decided we wanted a fully integrated approach to requirements and quality management, and that’s exactly what MatrixALM and MatrixQMS delivers.”

Guillaume continues: “Of all the vendors we evaluated, Matrix Requirements impressed us the most by far. MatrixALM and MatrixQMS make it easy for our teams to collaborate on documents, while preserving a complete and immutable audit trail of all changes and approvals.”

Achieving a fast deployment

With expert support from Matrix Requirements, Bruxless deployed and configured the new solutions to assist its quality and development teams.

“Support is critical to us, and Matrix Requirements performs very well in this area,” adds Guillaume. “The documentation for MatrixALM and MatrixQMS is comprehensive and accessible, answering most of our deployment-related questions. Additional support is only an email away.”

Using MatrixALM, Bruxless can automatically manage the complex dependencies between hundreds of requirements, risks, test cases and test results, and generate traceability matrices at the touch of a button. And with MatrixQMS, the company receives automated alerts whenever documents are modified—helping to ensure consistent alignment with the latest quality policies, procedures, and work instructions.

“After just three months, everyone in the business was fully trained and self-sufficient on the Matrix Requirements platform. We find the solutions very intuitive,” states Guillaume.

Ensuring audit-readiness

Today, Bruxless uses the Matrix Requirements solutions to create and manage the content of its technical file and quality manual in the runup to its first regulatory submission. As it prepares to apply for authorization for a clinical study, Bruxless is confident that it has audit-ready documentation that will meet regulatory requirements.

Johanna says: “We have over 300 project-related documents, and keeping track of the dependencies between our design objects manually would simply be too complex to manage with manual tools. For that reason, automated change control in the Matrix Requirements platform is extremely valuable. Matrix Requirements is a crucial tool that we rely on as an integral part of our business and processes.”

Guillaume agrees: “Matrix Requirements allows us to focus on our core competency—medical device development—while they look after and simplify document management. In the coming months, we will request authorization for a clinical study of our device. By streamlining our quality management processes, we estimate that we’ve improved our efficiency by up to 20%—and thanks to our Matrix Requirements solutions, we’ll be able to export the information our regulator needs within a matter of seconds.”

Planning for the future

Looking ahead, Bruxless plans to expand its use of MatrixALM and MatrixQMS to further enhance the efficiency of its requirements and quality management processes. By leveraging built-in API integration with Slack, the company will enable all employees to receive instant, automated alerts whenever a procedure or work instruction changes. And by connecting MatrixALM with GitHub, the company aims to fully integrate its continuous integration and continuous delivery (CI/CD) toolchain.

Guillaume comments: “The ability to automatically link requirements and test cases in MatrixALM with builds and test results in GitHub will allow us to improve the repeatability and efficiency of our development process significantly.”

As it sprints ahead on its development journey, Bruxless is convinced that it has found the optimal partner for regulatory success. “Matrix Requirements has the best support I’ve ever experienced; when I email them a question, they always come back with an insightful response—usually in less than 10 minutes,” concludes Johanna. “With MatrixALM and MatrixQMS underpinning our work, we’re in a very strong position to keep our product development process moving forward on schedule.”