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With the BAYOOSOFT Risk Manager, we support you on the efficient and standard-compliant path to technical documentation
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“We benefit enormously from the synergetic structures that have been created, because the time required for audits is much less than before. We also have fewer deviations in risk management and very unproblematic product approvals across all risk classes,” René Schmidt, former Senior Manager and Team Leader Regulatory Affairs Excellence at PAUL HARTMANN AG.
Medical professionals and patients rely on HARTMANN’s product brands in the incontinence management (e.g. MoliCare®), wound care (e.g. Zetuvit®) and infection management (e.g. Sterillium®) segments every day. This is what the Group brings to the market with its brand promise “Helps. Cares. Protects.” expresses this.
The HARTMANN GROUP is a leading European supplier of system solutions for medicine and care. Founded in 1818, the company is present in more than 130 countries with its products and solutions.
However, with an ever-growing product portfolio, over 10,000 employees and international locations, a new challenge emerged in 2016: in order to improve performance – in terms of the application of risk management for medical devices and usability engineering – and to ensure process compliance in the long term, it was necessary to drive forward the harmonization of processes and tools within the company.
René Schmidt, former Senior Manager and Team Leader Regulatory Affairs Excellence at PAUL HARTMANN AG, recalls: “In order to achieve targeted, fast and efficient product approvals in the respective markets, we needed a standardized approach.” Heterogeneous Excel files, risk management with pure FMEA (Failure Mode and Effects Analysis) and without interfaces between product and process risk management were to be replaced by a tool-based solution.
As part of projects for the global harmonization of processes, procedures and solutions, René Schmidt took over the topics of risk management for medical devices and usability engineering from 2016 and thus also the technical introduction of a new tool. In this context, the functionality of the then BAYOOSOFT Qware® Risk Manager (now BAYOOSOFT Risk Manager) was being tested. The recommendation of an external consultant drew the group’s attention to the solution shortly beforehand – and after an analysis of various PRM systems, BAYOOSOFT Risk Manager was shortlisted. “First of all, I understood the mindset of Risk Manager to check whether we could transfer our established content to the solution,” says René Schmidt.
One challenge in using the solution, however, came with the growing number of users in the company. As a result of a new release, however, the situation has improved significantly. “Then as now, it was important that we always had a good exchange and fast support from the IT colleagues at BAYOOSOFT,” adds René Schmidt.
What effect does the Risk Manager have on the work and marketing of new products? With the transition to the Medical Device Regulation (MDR), HARTMANN created a condition: All product risk files had to be based on BAYOOSOFT Risk Manager – or equivalent. “This enabled us to submit very comprehensive, harmonious risk files for all products to our notified body and incorporate the feedback via our templates and key user meeting structure,” says René Schmidt.
“We benefit enormously from the synergetic structures that have been created, as the time required for audits is much less than before. We also have fewer deviations in risk management and very unproblematic product approvals across all risk classes.” With several hundred different product files and many thousands of medical devices all covered by the BAYOOSOFT Risk Manager, this is a very worthwhile relief.
What else convinces René Schmidt about the BAYOOSOFT Risk Manager? The ability to create customized derivations of a risk management file for each country-specific target market for the submission of the
With the BAYOOSOFT Risk Manager, we support you on the efficient and standard-compliant path to technical documentation
Get to know our solution for 30 days. Click here for the TRIAL.