Published On: 9. July 2024

SCHMITZ medical GmbH – Simplified risk management with a growing product portfolio

SCHMITZ medical GmbH is a medium-sized family business in its fourth generation that specializes in the development, manufacture and international distribution of medical furniture for hospitals and doctors’ surgeries. These include operating tables, patient transporters and various treatment chairs. SCHMITZ has achieved a leading market position through continuous development and a high standard of quality and functionality. As a result, risk management has become increasingly important over the years.

Challenge: Maintaining an overview despite product growth

As the product portfolio grew over 15 years ago, working with risk management files became increasingly important for SCHMITZ. SCHMITZ has grown and new products and product revisions have been added. As a result, more and more risk analyses became necessary. Microsoft Excel® spreadsheets were ultimately no longer able to meet this requirement, so a systematic solution was needed to simplify and speed up the relevant processes. SCHMITZ’s aim was also to enable several employees to work on a risk file in parallel so that their processes could be designed even more effectively.

Opting for the market leader

After online research into possible software solutions that could meet SCHMITZ’s requirements, those responsible finally opted for BAYOOSOFT Risk Manager – in its version at the time as Qware Riskmanager. Richard Pellengahr, who is now responsible for risk management at SCHMITZ, explains in an interview: “I wasn’t involved in the introduction of Qware Riskmanager at the time, but colleagues told me that the solution was introduced smoothly in our company – which is certainly also due to the intuitive operation of the software.”

One software solution, many advantages

In addition to the intuitive structure of BAYOOSOFT Risk Manager, Richard Pellengahr and his team are convinced by other advantages in their day-to-day work. He particularly appreciates the guided process that users of BAYOOSOFT Risk Manager go through step by step – from the initial risk management plan content to the final report. This simplifies the work and ensures that nothing is forgotten. “All the necessary data is collected in one place, which contributes to greater clarity,” says Richard Pellengahr. The software also provides interim results that can be easily retrieved and presented to auditors, for example.

“It goes down particularly well with auditors if you can show them the tool and how it works,” adds the risk management officer.

The necessary documents can also be compiled quickly and easily for colleagues from the Regulatory Affairs department, Richard Pellengahr continues. The BAYOOSOFT Risk Manager is also suitable for usability management.

Support even after the purchase

Regular updates always offer new features and enhancements for the software solution. “And if my team or I have any questions or challenges, BAYOOSOFT’s support is always there to help us,” says Richard Pellengahr. “That’s another reason why I can recommend BAYOOSOFT Risk Manager. We really enjoy working with the software solution and always have friendly contacts at BAYOOSOFT.”

Your efficient and compliant approach to Technical Documentation

Your validated solution concerning documentation processes of Medical Devices and In Vitro Diagnostics – On the way from risk management, regulatory and product requirements to Usability and Clinical Evaluation: Digitize interlinked processes with BAYOOSOFT Risk Manager and reduce documentation efforts sustainably while minimizing redundant data at the same time.

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