EFF'INNOV Technologies Success Story

Driving innovation

For more than 15 years, EFF'INNOV Technologies has delivered expert research and development (R&D) services to businesses across multiple sectors. A specialist designer, developer and integrator of electronic embedded systems, the company’s offering ranges from consulting and prime contracting to turnkey solutions.

After many years of R&D success, EFF'INNOV Technologies decided to expand into the field of medical device development. The aim was to help businesses in its domestic market in France and beyond to build high-quality software and hardware devices.

Targeting new markets

As it embarked on this new stage of its business growth journey, EFF'INNOV Technologies knew that it would be crucial to demonstrate its compliance with key regulatory requirements in Europe and North America. In particular, the organization needed to establish an effective quality management system for medical device development, as set out in ISO 13485.

François Audéon, Chief Technology Officer of EFF'INNOV Technologies, elaborates: “One of the key requirements of ISO 13485 is full traceability for all documentation, including requirements, specifications, risks and tests. As soon as we started work on our first medical device R&D project, we realized that manual traceability analysis was to take way too much time, which we would be better off spending on adding value for our customers.”

Facilitating compliance

EFF'INNOV Technologies set out to find a more efficient approach to ISO 13485 compliance. After reviewing requirements management solutions from several leading vendors, the company selected MatrixALM—an easy-to-use software platform that enables automated traceability analysis.

“We felt that using spreadsheets and text documents for requirements management was too risky, as manual tools make it difficult to keep track of dependencies between documents and keep everything up to date,” François explains. 

“Building our own automated tools was also out of the question, as anything we created would need to be validated as part of our ISO 13485 certification, which would have been a highly complex and resource-heavy process. With MatrixALM, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”

Deploying rapidly

Working with Matrix Requirements, EFF'INNOV Technologies deployed and configured MatrixALM to support its new R&D workflows for medical devices. Within less than three months, the company was fully up and running with the solution.

“The Matrix Requirements team is incredibly helpful and supportive, which was especially valuable when we were just getting started with MatrixALM,” recalls François. “Getting support is always very simple, and we typically receive answers to our questions within the same working day—something that I’ve rarely experienced from other technology providers we have worked with.”

He adds: “Another area where Matrix Requirements really shines is cost-efficiency. When it comes to price and performance, we’ve found the traceability analysis in MatrixALM to be far superior to all the other requirements management solutions we evaluated.”

Streamlining R&D workflows

Today, MatrixALM is tightly embedded in the company’s business processes. At the beginning of a new medical device R&D project, EFF'INNOV Technologies employees use standard, repeatable templates in MatrixALM to capture and document requirements and specifications for all software and/or hardware components, along with their associated risks, test cases and test results. Once a design has been finalized, the company also uses the Matrix Requirements solution to generate documentation for submission to regulatory bodies.

François comments: “One of the capabilities of MatrixALM that I appreciate most is that when you make a change to a document, it highlights all the dependencies automatically—helping us to keep documentation up-to-date and audit-ready at all times.”

10x faster traceability analysis

After almost a decade of success with MatrixALM, EFF'INNOV Technologies is achieving its goal of delivering high-quality R&D services for the medical device industry. The company has worked on more than 15 medical device projects to date, and now generates around 40% of its annual revenues from these development activities.

“When we start work on a new medical device development project, the first thing we do is input all the client’s specifications into MatrixALM—enabling us to trace the relationships between them instantly,” says François. “While manual traceability analysis is time-consuming and error prone, MatrixALM is fast, accurate and effective. In fact, we estimate that we can perform traceability analysis in the Matrix Requirements solution 10-times faster than with manual tools.”

Achieving audit success

As well as accelerating traceability analysis, EFF'INNOV Technologies has found that MatrixALM delivers significant advantages during audits. With clear links between requirements, risks and other documentation items, the solution empowers the company to effectively demonstrate its compliance with regulatory standards.

François confirms: “For ISO 13485, we must renew our certification every three years and complete intermediate audits every year. When we engage with auditors, they often comment on how impressed they are with the quality of our traceability matrices.”

EFF'INNOV Technologies also uses the solution to help address standards such as IEC 62304. Using the Matrix Requirements Query Language (MRQL), the company can quickly generate a comprehensive table of risks related to medical device software and classify them based on their potential to cause injury.

Reducing costs by 70%

François says: “Under the Medical Device Regulation, traceability and risk management are two of the key focus areas. With MatrixALM, we can streamline and automate these processes, which helps us spend less time on repetitive manual tasks and more time on value-added R&D services. Overall, we estimate that using the Matrix Requirements solution instead of manual tools reduces our annual operational costs by as much as 70% a year.”

He concludes: “Over the years, we’ve helped our clients create innovative solutions for blood-pressure monitoring, electrocardiogram testing, blood oxygen tracking and much more. MatrixALM is one of the main tools that we use to help our clients develop their products, and we’re looking forward to many more years of successful partnership with Matrix Requirements.”