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Qware® Riskmanager

The efficient way for technical documentation

Since 2000 Qware® Riskmanager has been the global market-leading software solution for creating the technical documentation. In addition to the creation of Risk Management Files in accordance with ISO 14971:2012, of the Usability Engineering File in accordance with IEC EN 60601-1-6 / EN 62366, the Conformity Report for medical electrical equipment in accordance with IEC 60601-1, 3rd Edition as soon as the essential requirements in accordance with MDR 2017/745 and IVDR 2017/746, Qware® Riskmanager also offers a fully integrated Requirements Engineering module.

In a clearly structured environment, the compiled knowledge is developed across projects in the self-learning knowledge base of the Qware® Riskmanager. The information is made available to the authorised employees throughout the company. Knowledge loss due to employee turnover is avoided. Particularly effective measures are identified and suggested. Your development and approval processes will be accelerated with Qware® Riskmanager. By continually adapting the Qware® Riskmanager to the changing regulatory conditions and field-tested reports, you can concentrate on the content of your technical documentation instead of being delayed due to time-consuming formatting.

Regulatory requirements at a glance

RISK MANAGEMENT IN ACCORDANCE WITH DIN EN ISO 14971

A medical device is used in or at the body of humans and poses a certain risk. On this occasion there consists a high-grade level of protection. A remaining residual risk has to be weighed with the usefulness of the product. In the German, European and American medical product legislation a risk management for medical devices and in vitro diagnostics is consistently required.

Therefore the internationally accepted standard ISO 14971 established a procedure by which risks that are associated with medical devices and their accessories could be detected, estimated, valued and verified as well as the effectiveness of these controls are monitored. The requirements of the standard are valid during the various stages of the product lifecycle of a medical device.

For the last 16 years, Qware® Riskmanager has been the global market-leading software solution for completely integrated creation of Risk Management Files in accordance with ISO 14971:2012. In a clearly structured environment all relevant information are captured, saved centrally and secure for revision and fine-grained, dynamically interlinked. You have the choice whether the risk management should be realized based on the FMEA to the standard DIN EN IEC 60812 or based on the Preliminary Hazard Analysis (PHA). An integrated project- and version management with a fine-granular permissions structure, monitoring the action management system incl. validation & verification, the implementation of the risk inventory with automatic reminders and an integrated template management with an auto-adaptive knowledge database as well as automated proposal functions, e.g. for identifying particularly effective measures, accelerate and simplify the creation of the risk management dossier.

USABILITY ENGINEERING IN ACCORDANCE WITH EN 62366 & IEC EN 60601-1-6

In addition to the risk management process as defined in ISO 14971 there must be made specific requirements to the usability of medical devices. Specific requirements for validating and verifying of the usability of medical devices and medical electrical equipment are regulated in the standards EN 62366 and EN 60601-1-6.

Qware® Riskmanager integrates the usability engineering process completely into the risk management in accordance to ISO 14971. Moreover Qware® Riskmanager guides you step by step to the usability engineering file with the aid of a tried and tested macro structure. From intended conditions of use via medical indication, intended patient- and user-groups, usage scenarios, main operating functions and requirements up to validation concepts and verification e.g. with usability tests, focus groups, expert reviews or cognitive walkthroughs - Qware® Riskmanager covers all matters relating to IEC EN 60601-1-6 and EN 62366 and accelerates your work processes.

ESSENTIAL REQUIREMENTS IN ACCORDANCE WITH MDR 2017/745 AND IVDR 2017/746

To place a medical device on the European market it has to comply with the fundamental requirements of the applicable directive in each case. On this occasion three EU directives will be applicable:
Medical Device Regulation / MDR 2017/745 for medical devices and active implantable medical devices
In-Vitro Diagnostics Medical Device Regulation / IVDR 2017/746 for vitro diagnostic

Depending on the type of product there must be applied further directives if necessary. In any country of the European Union and in the associated countries these EU-directives are implemented by the use of national laws. In Germany and Austria this takes place with the medical products law (MPG). In Switzerland it takes place with the Therapeutic Products Act which is strongly inspired by the EU-directives.

In practical terms questions had to be answered depending on the type of product. These questions concern: the construction of the products concerning the principles of integrated security, the entitlement or minimization of the risks, the information for the users of the residual risks for which protection measures cannot be taken, the storage and transport, the information regarding the chemical and biological characteristics, the requirements of construction and manufacture, the infection and microbial contamination, the environmental conditions, the radiation protection and the protection against thermal hazards, the protection against risks as a result of submission of energy or substances to the patient, the requirements of products for self-testing or the marking.

Qware® Riskmanager deposit the set of rules of the normative requirements, guides the user with an intelligent questionnaire to relevant issues and links consisting data of the risk management whereby a double data acquisition could be avoided. This will be documented in audit-secure reports and accepted from Notified Bodies. 

COMPLIANCE REPORT FOR MEDICAL ELECTRICAL EQUIPMENT IN ACCORDANCE WITH IEC EN 60601-1 3.1 EDITION

For medical electrical systems a report of conformity in accordance with IEC EN 60601-1 must be created. Depending on the product you have to apply collateral standards (EN 60601-1-x) and particulate standards (EN 60601-2-y).

The importance of risk management was considerably strengthened in IEC 60601-1 3.1 edition. The risk management in accordance to ISO 14971 is an essential component of the security concept of medical devices. The manufacturers of medical electrical systems have to establish an efficient and secure process to avoid redundant data and inconsistent data stocks.

In addition to this complex challenges more than 1.500 tests on applicability must be taken into account and provided in the form of inspection reports. Qware® Riskmanager simplifies this process and creates the complete compliance report in according to IEC 60601-1. Double acquisitions lapse completely, non-relevant tests will be filtered out automatically through intelligent querying. You will be guided interactively through the complete standardization process.

REQUIREMENTS ENGINEERING

Requirements Engineering is an important component of an efficient and error-free development of complex systems and especially in the conception of complex products or systems where the production occurs collaborative of particular importance.

In the field of medical devices the processes have to be defined and implement. Furthermore it is valid to cover the specific requirements for the traceability and to verify and validate the requirements.

Qware® Riskmanager offers a fully integrated solution for acquisition and maintenance of the requirements with its Requirements Engineering module. The requirements could be linked with functions and measures on the one hand, on the other hand the requirements could be created of consisting measures. Usability relevant requirements are integrated in the Usability Engineering process whereby a redundant data collection could be eliminated.

MEDICAL IT-NETWORKS ACCORDING TO IEC 800001-1:2010

The market-leading system Qware® Riskmanager offers the functionality to map requirements related to risk management systems for Medical IT-Networks and enables network operators to satisfy the regulatory requirements in accordance with IEC 80001-1. The module “Risk Management according to IEC 80001-1” allows the planning and documentation of Medical IT-Networks throughout the entire life-cycle. Requirements, manufacturers, network components, changes and monitoring can be documented comprehensibly

The structured and field-tested environment of the Qware® Riskmanager supports efficiently by identifying risks early in the development process. The documentation of the risk analysis is carried out taking into account the protection goals of security, effectiveness and data and system security. The risk analysis and the measures management of the Qware® Riskmanager help to reduce possible threats that can arise when networking IT networks and medical devices. In addition, with the reliable and secure fulfillment of FDA and Notified Body requirements, approval processes are accelerated and time-to-market time is reduced.

VALIDATION IN ACCORDANCE WITH  GAMP 5 FOR QWARE® RISKMANAGER  

With the medical device standard ISO 13485: 2016, the validation of computerized systems becomes a fundamental part of the quality system, ensuring transparency and consistency in safety-critical processes and environments. For example, proof must be provided that the software specifications conform to the user requirements and fulfill the intended purpose. This means for manufacturers who use proprietary solutions, such as Microsoft Excel or Word files, during their development process, e.g. in risk management or product documentation, that they need to validate these solutions. Depending on the size of the sheets and the existing validation know-how, the effort involved in such a validation can easily amount to 150 hours and in the future, every change requires revalidation.

In order to spare the users of the Qware® Riskmanager these often unproductive expenses, the Qware® Riskmanager has been validated and is now available as a pre-validation package. Based on the GAMP 5 Guidelines for Computer-Aided Validation, the market-leading software solution has gone through the validation process as Category 4 software, successfully completing all aspects of requirements, from configuration specifications to acceptance testing.

  • Time savings - quickly and effectively perform the validation process for Qware® Riskmanager with the Quick-Start Guide
  • Streamline your processes and save costs: more than 500 pages of prepared validation work for your sustainable and standards-compliant documents
  • Sustainability Included - all necessary updates for each software update for re-validation
  • Special - BAYOOMED takes over the validation of the Qware® Riskmanager according to GAMP 5 with a special service package.
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