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
      • Continuous Development since 1998 – Version History
      • Selection from Our Customer List
  • Modules & Features
    • Modules
      • Risk Management
      • Usability Engineering
      • Essential Requirements
      • Medical Electrical Equipment
      • Machinery Directive
      • Requirements Engineering
      • Clinical Evaluation
      • Software Lifecycle Process
      • Medical IT Networks
      • REST API
      • Advanced Reporting
      • Pre-Validation Package
    • Features
      • Preliminary Hazard Analysis
      • Failure Mode and Effect Analysis
      • Structured Work According to Lifecycle Phase
      • Medical Device Classification
      • Post Market Surveillance
      • Self-Learning Knowledge Database
      • Fine-Grained Authorization Management
      • Visualizing with the Grey Box
  • Services
    • Services
      • Individual Services
      • Medical device classification
      • Software Validation – Your Service Options
      • License Model
      • System Requirements
      • Frequently Asked Questions
    • Contact
      • Upcomming Events
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    • Company
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BAYOOSOFT Risk Manager

Event overview for the validated approval accelerator

BAYOOSOFT Risk Manager is the validated approval accelerator for conveniently generating auditable technical documentation for medical devices. The globally leading medical device manufacturer has been providing support with a process-oriented approach in the preparation of risk management documents according to ISO 14971, in usability engineering according to IEC 62366, the creation of conformity reports according to IEC 60601-1 as well as the fulfillment of the essential requirements of MDD, IVDD, MDR and IVDR since 2000. At the same time, BAYOOSOFT Risk Manager includes fully integrated requirements engineering, which significantly simplifies the traceability of requirements. For clinics and hospitals, we offer an extension module for medical IT networks according to IEC 80001-1.

The intuitive user guidance, examples provided and ready-made document templates make it easy to get started. The self-learning knowledge database results in synergy effects between projects and helps to utilize developed know-how throughout the company. At the same time, BAYOOSOFT Risk Manager meets the requirements of FDA 21 CFR Part 11.
A clear and consistent approach with the reliable application accelerates market approval and has a positive effect on expended time and costs: Our customer base of more than 800 customers reported up to 62% faster approvals for medical devices thanks to BAYOOSOFT Risk Manager.

Have a look for yourself and get to know BAYOOSOFT Risk Manager better as part of an online product presentation:

Upcoming online product presentations

  • Digitize your processes with BAYOOSOFT management solution (ger) – 22.02.2023
    • Digitize your processes with BAYOOSOFT management solution (ger) – 22.03.2023
      • Digitize your processes with BAYOOSOFT management solution (ger) – 26.04.2023
        • Can’t find a suitable online event for you?

          Book your individual product presentation today!

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          Exhibitions and conferences

          BAYOOSOFT Risk Manager on tour

          Alternatively, you can visit us at one of the upcoming exhibitions and conferences and get talking to our experts for risk management and technical documentation for medical devices. BAYOOSOFT Risk Manager will be present at the following events:

          Upcoming fairs & conferences

        • BAYOOSOFT Risk Manager @DMEA 2023
          • BAYOOSOFT Risk Manager @MedTechLIVE 2023
            • BAYOOSOFT Risk Manager @Infomarkt der Möglichkeiten 2023
              • BAYOOSOFT Risk Manager @Medica 2023
                • News

                  • BAYOOSOFT @ MEDICA 202231. October 2022 - 18:52
                  • Medizintechnik Klinische BewertungClinical Evaluation: Seamless documentation13. October 2022 - 13:32
                  • Agile DevelopmentAgile IEC 62304: How you can use the standard in the development process10. August 2022 - 16:56
                  Contacts at BAYOOSOFT 

                  Svenja Winkler
                  CEO
                  [email protected]

                   

                   

                  Franziska Weiß
                  Head of Sales [email protected]

                  Darmstadt
                  Lise-Meitner-Straße 10
                  64293 Darmstadt

                  Munich
                  Aidenbachstraße 54
                  81379 München

                  Berlin 
                  Mariendorfer Damm 1-3
                  12099 Berlin

                  Phone: +49 (0) 6151 – 86 18 – 0
                  Fax: +49 (0) 6151 – 86 18 – 150

                  Contact: [email protected]
                  Support: [email protected]
                  Jobs: [email protected]
                  Press: [email protected]

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