Published On: 17. May 2024

Global ready

Process harmonization for PAUL HARTMANN AG

“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”.

René Schmidt, former Senior Manager and Team Leader Regulatory Affairs Excellence at PAUL HARTMANN AG in our Success Story

Maintaining an overview with a growing product portfolio and over 10,000 employees

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 table 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 ensure process compliance in the long term, it was necessary to drive forward the harmonization of processes and tools within the company.

 

Standardized approaches for targeted, fast and efficient product approvals

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 uniform 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 (today: BAYOOSOFT Risk Manager) was 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 Risk Manager way of thinking in order to check whether we could transfer our established content into the solution,” says René Schmidt.

Implementation of the BAYOOSOFT Risk Manager

The result: a transfer was possible without any problems – and the software solution also fulfilled other important requirements of PAUL HARTMANN AG. “On the one hand, we were looking for a tool that could be accessed by as many employees as possible; on the other, we wanted to use this tool-based solution to establish standardized formulations for risk files that build on each other and can be linked easily,” says René Schmidt. “And of course – in terms of time management – it was also important to us that the content could be reused.” The holistic approach of being able to consider usability and risk management together and to build up documents step by step and interactively was a great benefit and led to the decision in favor of BAYOOSOFT Risk Manager.

The implementation of the solution at HARTMANN finally began at the end of 2016 with a one-day session by a BAYOOSOFT contact person, in which risk management and usability engineering were first discussed and then the introduction to the system followed using an example. “My team still follows this approach when training new key users,” says René Schmidt. “First there is process training, then we get to know the Risk Manager.”

 

Overcoming challenges together

One challenge in using the solution, however, came with the growing number of users in the company. However, the situation has improved significantly as a result of a new release. “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 created on the basis of 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 products all covered by BAYOOSOFT Risk Manager, this is a very worthwhile relief.

What else convinces René Schmidt of the BAYOOSOFT Risk Manager? The ability to generate customized derivations of a risk management file for the submission of country-specific technical documentation for each country-specific target market. “Validation out of the box: That was also an argument for choosing Risk Manager,” he adds.

A decision that René Schmidt and PAUL HARTMANN AG have confirmed even after more than five years of working with the BAYOOSOFT Risk Manager: “I am convinced by the Risk Manager and have never seen a comparable tool that is so consistent and well thought out.”

 

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: Digitalize interlinked processes with BAYOOSOFT Risk Manager and reduce documentation efforts sustainably while minimizing redundant data at the same time.

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