Published On: 13. February 2025

Kulzer GmbH – Optimized Risk management for high quality standards and satisfied customers

Kulzer GmbH is a leading company in the dental industry based in Hanau. The company is characterized by its high quality, research expertise and customer orientation.

Optimized risk management is particularly important for them in order to guarantee the high quality standards and safety of their products, meet regulatory requirements and secure the trust of customers and partners in the long term.

The challenge: From Excel to automated risk management

100 files for 100 products – this was the reality for Kulzer just 10 years ago. A separate Microsoft Word® and Excel® document was maintained for each product. As a result, a lot of data was redundant and it was virtually impossible to maintain it in accordance with the rules.

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The only difference between some of Kulzer’s products is a different color or consistency. However, each product requires its own risk management file, so a separate Microsoft Word® and Excel® document had to be created for each variance and subjected to an annual review.

In 2013, the risk management team at Kulzer set out to find a suitable software solution in order to save costs.

Opting for the market leader

After an Internet search, the choice quickly fell on BAYOOSOFT Risk Manager. The on-site introduction to the tool at BAYOOSOFT then finalized the decision. It was not only the software solution itself, but also the people behind it – from sales to the support team – that convinced Kulzer.

Claudia Koenen, Risk Manager at Kulzer, transferred all content from the old documents after the introduction of BAYOOSOFT Risk Manager. Since then, there are still 15 main files. “In order to organize our many products clearly, we have grouped them together,” explains Claudia Koenen. “There is now one application file, one production file and, if necessary, one development file per product group.” The main file with PMS data now has to be maintained above all.

Kulzer also uses the usability module and requirements engineering to optimize processes.

One software solution, many advantages

The BAYOOSOFT Risk Manager was able to solve a number of problems at Kulzer. “Overall, you feel more confident about meeting regulatory requirements and you can’t forget anything,” says Claudia Koenen. The knowledge database also helps her to use standardized terms across all files.

“The Risk Manager proves to be extremely helpful, especially during audits and when notified bodies request an interim status,” says the Risk Manager. “This is because all relevant documents are always available and can be presented directly in the software.” It is also a great advantage that Kulzer uses the Pre-Validation Package and can therefore speak of validated software.

Support even after the purchase

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Claudia Koenen, Risk Manager at Kulzer

Claudia Koenen has fond memories of the user meetings in Darmstadt, which now take place online. In the open webinars, there is time for questions and an exchange with other BAYOOSOFT Risk Manager users.

She also emphasizes: “The cooperation with BAYOOSOFT is characterized by fast communication. If there are any problems, someone is always available via MS Teams and requests are implemented directly. BAYOOSOFT’s proximity to our company headquarters also gives me a good feeling”. She is happy to recommend BAYOOSOFT and the Risk Manager to others.

Your efficient and compliant approach to Technical Documentation

Your validated solution for documentation processes in the medical device and IVD industry: With BAYOOSOFT Risk Manager, you can digitize linked workflows – from risk management and regulatory requirements to clinical evaluation.

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