Risk Manager
  • Solution
    • The Validated Approval Accelerator
      • Risk Management According to ISO 14971
      • Usability Engineering According to EN 62366
      • Essential Requirements According to MDR 2017/745 & IVDR 2017/746
      • Conformity Report for Medical Electrical Equipment According to EN 60601-1
      • Risk Management for IT Networks According to IEC 80001-1
      • Process Validation According to DIN EN ISO 13485
      • Clinical Evaluation According to MDR 2017/745 & MEDDEV 2.7.1
      • Software Lifecycle Process According to IEC 62304
    • References
      • What Our Customers Say – Success Stories
      • MST-Instrumente: Work and Time Savings
      • University Hospital rechts der Isar: Faultless Documentation and Achievement of the IEC 80001-1
      • Euroimmun: Cost Savings in Usability Engineering
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      • Medical IT Networks
      • REST API
      • Advanced Reporting
      • Pre-Validation Package
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      • Preliminary Hazard Analysis
      • Failure Mode and Effect Analysis
      • Structured Work According to Lifecycle Phase
      • Medical Device Classification
      • Post Market Surveillance
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      • Fine-Grained Authorization Management
      • Visualizing with the Grey Box
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Risk management of IT networks in hospitals

Protect critical infrastructure by considering IEC 80001-1

As part of the indispensable social infrastructure, hospitals are of outstanding importance for civil protection, which is why a large number of these facilities will also have to meet the requirements of the IT security law for these critical infrastructures in the future. The risk analysis, which is described in the context of IEC 80001-1, will be an important basis for the recording and evaluation of an actual threat situation.

Effort reduction through tool support

In order to avoid a permanent increase in IT and medical technology costs through the establishment of risk management, the BAYOOSOFT Risk Manager supports the fulfillment of these requirements as a process accelerator. To this end, the market-leading software solution has been providing an extension for operators of medical IT networks since 2015 in addition to meeting numerous standards for medical device manufacturers.

Medical IT networks according to IEC 80001-1

IEC 80001-1 addresses all operators of IT networks who operate at least one medical device in this network. This standard primarily requires risk management over the entire life cycle of the IT network, i.e. as long as the medical device is part of the network. Riskmanager, market-leading solution, offers you as operator of such a medical IT network the possibility to fulfill these regulatory requirements for risk management. With the software module Risk Management according to IEC 80001-1 you can plan and document your IT networks. All requirements, manufacturers, network components, changes and monitoring can be carried out at a central point.

Accelerate the development and approval processes

With Riskmanager you spend your time on the content, not the form!

To get an overview of the process and the benefits of the software solution, BAYOOSOFT currently offers a free trial of the IT Networks module. An evaluation is worthwhile – not only for the reduction of expenses, but also for the protection of the social infrastructure component hospital against potential cyber attacks.

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News

  • Mensch stapelt Holzklötze mit Symbolen aus dem Medizinbereich zu einer PyramideRisk management in the development process of medical devices: Beginning and end?8. June 2022 - 16:42
  • IVDR – End of the transition period23. May 2022 - 8:42
  • Reanimation im KrankenhausHazards and risks: This applies in risk management for medical devices10. May 2022 - 9:11
Contacts at BAYOOSOFT 

Svenja Winkler
COO/Director Management Solutions
svenja.winkler@bayoo.net

 

 

Franziska Weiß
Head of Sales franziska.weiss@bayoo.net

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