Design, quality and safety: LiKAMED uses the Risk Manager
Whether medical couches and beds for areas of application such as dialysis, blood donation and oncology, shock wave therapy devices or powder coatings for customers’ external products – LiKAMED’s product range is diverse.
The company has been successfully active in the medical sector for over 40 years. What is special about it? Without exception, all LiKAMED products are developed, tested, produced and assembled by their own experts.
From Excel to automated risk management
The BAYOOSOFT Risk Manager has been in use in the company for more than 10 years. “We all know that risk management is an important topic and needs proper documentation. My colleagues had previously documented everything in Excel tables, but that was incredibly time-consuming,” recalls Lucas Greulich, quality assurance expert at LiKAMED. Because of the many different products, there used to be hundreds of documents that had to be created individually.
“Today, with BAYOOSOFT Risk Manager, we have all product families collected and uniform in one solution,” says Lucas Greulich. When working in Regulary Affairs, approvals, also for the international market, are part of the daily business. “I honestly can’t imagine working only with Excel lists any more,” laughs Lucas Greulich and adds: “Risk management is an issue in every country. With one click, I can export any document I need.”
He did not need any training or familiarisation: Handling and working with the software solution is intuitive and the application guides the user through the tasks in a targeted manner. “The BAYOOSOFT Risk Manager was a great help for us, especially with the changes that the MDR brought with it,” says Lucas Greulich. At no time were there any discrepancies in the documents or queries with the notified bodies, because they were able to work very well with the exported documents.
It is precisely this security and clarity that have convinced LiKAMED so much. “I can always see immediately in the dashboard where information is still missing and I have to add something. Therefore, I don’t have to worry about whether I might have forgotten something.”
A “living software”
But it was not only the software itself that was decisive in this long-term cooperation. “You don’t just have a programme, you also have close contact,” Lucas Greulich appreciates. This is also what makes the solution a “living software”: “You can see that this solution is constantly being further developed for the users and that feedback is being implemented. Even small things are added right away.
For example, LiKAMED only used the risk management module at the very beginning, then gradually expanded it to include, among other things, the basic requirements, usability engineering and, most recently, the extension module on machine guidelines. For him, the open communication is particularly recommendable. “The BAYOOSOFT Risk Manager team approaches us at regular intervals and asks directly what could be improved. We already know that we will definitely be adding to our modules in the future,” Lucas Greulich is certain.