OCULUS Optikgeräte GmbH – System and structure for greater product safety
OCULUS Optikgeräte GmbH, based in Wetzlar, Hesse, has been developing and producing high-precision diagnostic devices for ophthalmology and optometry for over 125 years. As an internationally active medical technology company, OCULUS supplies its products to over 100 countries worldwide.
In an environment in which patient safety and regulatory requirements are particularly high, structured and comprehensible risk management is essential – both for product quality and for proof of conformity during market placement.
Initial situation: Microsoft Word chaos instead of a system
Matthias Krug, Head of Product Safety and Risk Management at OCULUS, remembers the situation well before the introduction of BAYOOSOFT Risk Manager: “At the time, our risk management was a pure Word solution: confusing, inefficient and no longer up to date.” This was a real risk, especially in a strictly regulated environment such as medical technology. Documents were scattered around, responsibilities were often not clearly defined and there was often no overview of the current status of individual assessments.
The desire for a resilient solution
The need to put risk management on a new footing was growing, not least in view of audits and the requirements of the MDR. An internal project team began to systematically search for a digital application that would not only meet the regulatory requirements, but could also be integrated into OCULUS’ existing process landscape. ” We wanted a tool that would guide us through all the requirements in a structured way and be easy to use at the same time,” says Matthias Krug.
Decision in favor of the BAYOOSOFT Risk Manager
BAYOOSOFT Risk Manager was quickly chosen. The main deciding factors were the mapping of standards to be met, the clear structure and the focus on medical device manufacturers. “It just felt good and we quickly had the feeling that it would suit us,” says Matthias Krug, describing the decision-making process. Even during the first demo, it became clear that this was not a generic risk tool, but a dedicated solution for the medical sector that would increase efficiency in workflows and management processes.
Introduction in several steps
The rollout took place step by step: First, existing processes were analyzed and then transferred to the new system in close coordination with BAYOOSOFT. Employee training was a key success factor. Acceptance stands and falls with an understanding of the system. This worked very well thanks to the intuitive interface.” After just a short time, work had already changed noticeably: clearer responsibilities, transparent evaluation including traceability and less coordination effort.
Cooperation at eye level
Matthias Krug also emphasizes the partnership-based and trusting cooperation with BAYOOSOFT. Both in the introductory phase and during ongoing operations, the technical and specialist support was always competent and solution-oriented: “We get quick, well-founded answers and you can tell that you are talking to people who really know their stuff.”
The OCULUS team also benefits from the continuous further development of the software solution. New functions such as graphical visualizations or the integration of additional standards make day-to-day work even easier.
Conclusion: A real quantum leap
Today, risk management is no longer just a regulatory obligation, but an integral part of the development and quality management departments. Matthias Krug is certain: “The BAYOOSOFT Risk Manager has helped us to turn a Word solution into a resilient, compliant system. That was a real quantum leap.”
