Error-free documentation and achievement of IEC 80001-1 protection goals with the BAYOOSOFT Risk Manager

Since 1834, the University Hospital rechts der Isar has developed from a district hospital into a supramaximal hospital with approx. 1200 beds covering the entire spectrum of modern medicine. With around 30 clinics, 20 interdisciplinary centers and numerous scientific institutes, more than 5,500 employees ensure the well-being of patients and the further development of medical research.

The path to automated risk management

Previously, risk management at the hospital was managed using Excel and Word documents. It was difficult to ensure a permanent overview of the various risk files. So the project team, led by Mr. Lauter, decided to look for a functional software solution.

During their research, the project team came across the Darmstadt-based software manufacturer BAYOOSOFT, which has been active on the market since 2001. The BAYOOSOFT Risk Manager is an automated software solution for the creation of technical documentation which, in addition to the basic risk management component in accordance with ISO 14971, also offers the medical device operator solution in accordance with IEC 80001-1. The University Hospital rechts der Isar implemented the Medical IT Networks and Medical Electrical Equipment modules.

The IEC 80001-1 standard is essential for the operation of medical devices in IT networks. To meet this standard, employees receive support from the BAYOOSOFT Risk Manager. Risks can be identified at an early stage, clear documentation guaranteed and centralized management ensured. The structured design of the Risk Manager enables error-free and comprehensible documentation for risks to networks and individual network components. The focus here is on compliance with the protection targets.

Time savings achieved

Thanks to the successful implementation of the software with the help of the BAYOOSOFT Service Team, the hospital staff were able to start processing the risk files in BAYOOSOFT Risk Manager promptly. Thanks to the clearly designed user interface, the trained team was able to quickly find their way around the software and take on the day-to-day work of risk management.

The same number of employees now work much more efficiently. There is an enormous time saving as far as the form of the documents is concerned. It is now more about content and the focus is on real improvement.

“Previously, we worked with complex Excel files that were easy to lose track of,” recalls Mr. Lauter. “Thanks to BAYOOSOFT Risk Manager, we were able to avoid this time-consuming workload. The software guides you through the process without errors, you can’t deviate intentionally or unintentionally, you can’t forget anything and you get a flawless result.”

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