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Why Qware® Riskmanager

Development of medical devices and putting them on the market entails the observation of extensive regulatory conditions. For this, one can refer to national laws and regulations, EU directives, FDA guidelines, product and process standards, and guidance documents – or one can refer to a quality management system.
Regulatory requirements have increased in number steadily over recent years - the draft of the planned EU Medical Device Regulation already provides for numerous discussions. For manufacturers of medical devices, this represents a steadily increasing amount of documentation, because that which has not been documented, will not, if there is any doubt, be made. Manufacturers of medical devices, in-vitro diagnostic devices or active implantable medical devices, therefore already "produce" a huge amount of "paper", and all indications are that this will increase even more.

“We muddle through”

“… because we’ve always done it that way” – this is how many risk management officers describe their in-house processes. The various components of the technical documentation are often created as static one-off solutions with office applications such as Microsoft Word or Excel. Over the years, growing projects lead to ever larger and more confusing document collections, which do not automatically incorporate accrued knowledge.
Often missing functionality is then made up for by complex cell references, (partially wild) formulas and VBA macros. At first, this alleviates the workload of the file’s creator, but over time causes a greater burden through the load on other colleagues, who cannot follow the calculations without an unjustifiable investment of time. The result: a new file is created, the projects become more and more unmanageable, inconsistent documents with partly contradictory contents proliferate, errors occur, and normative changes are recognized too late, if at all...
Few companies use Microsoft Word or Excel documents even for “simple" business tasks such as preparing invoices, delivery notes or credits. It is then all the more surprising to find the use of these tools in such a critical core of the company. The consequences can be serious, ranging from delays in launches and cost increases because of amendments to cases of product liability or refusal of product approval.

No more muddling through

To break free of this “document jungle”, the goal should be to break up monolithic documents into fine-grained data and to pass as much work as possible to specialized software tools. The advantages are obvious.

    Preventing redundant information

    Data appropriate to multiple medical devices (e.g. those sharing common components or functions), as well as information that satisfies separate yet parallel regulatory requirements, should be recorded and stored only once. Everywhere else, such information should be only referred to by links, so that the work process is simplified and accelerated. In addition to the associated savings in time and money, will also prevent such issues as, for example, the exact same risk having a different assessment in a compliance report for electrical medical devices to its assessment in a DIN EN ISO 14971 risk management file. Employees can thus concentrate on value creation rather than on comparing and synchronizing documents.


    Since only demonstrably qualified employees may edit and release regulative documents, the workload is falls mostly on a few and usually also well-paid employees. Freeing up these employees through automation of standard activities not only saves money, but also valuable time, which can be used for other projects. In addition, errors can be avoided and approval processes accelerated by automation, such as integrated plausibility checks.


    In fulfilling regulatory requirements for medical devices, the focus should be on the content, not on the exact form the data should be in for further processing. With uniform definition and naming of issues and situations across a company or product group, and the use of internationally agreed reporting formats with Notified Bodies, a standard software provides a supportive framework, which also can be transferred to other colleagues with little effort.

    Qware® Riskmanager is the world's leading software solution for the creation of technical documentation for manufacturers of medical devices and in-vitro diagnostic devices. In a clearly structured environment, all relevant information is collected, stored centrally under version control, and dynamically interconnected with a fine granularity. Redundant data do not exist, and with the press of a button, reports are generated automatically with the latest data.
    Qware® Riskmanager helps to detect risks early in the development process and to visualize risk distributions graphically. The intuitive user interface, bundled examples, and prepared document templates make it easy to get started. The self-learning knowledge base with automatic suggestions of further potential risks, possible sources, or the most efficient measures, facilitates the use of synergies between projects and accrued know-how across the whole company.
    For 18 years Qware® Riskmanager has successfully proven itself on the market, has been continuously adapted to normative changes and has been enhanced with new functionality. As an immediately useable, market-established, and cost-effective system, it accelerates development and approval processes. You spend your time on content, not on form.

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