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
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      • 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
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End of the MDR deadline 2017/745: How to use the time effectively

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28. April 2021/by Annika Pörner
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Donations instead of gifts: 10,000 euros for charities

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17. February 2021/by Julia Pfeffinger
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The Hospital Future Fund: Funding for IT Security

Editorial
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8. February 2021/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2021/02/shutterstock_357459272-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2021-02-08 09:58:052021-02-08 11:22:14The Hospital Future Fund: Funding for IT Security

Guide to German Medtech Companies 2021

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22. January 2021/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2021/01/Guide_Deckblatt.jpg 933 709 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2021-01-22 13:28:122021-01-22 13:31:44Guide to German Medtech Companies 2021

Virtuell Connected: A MEDICA 2020 Retrospective

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10. December 2020/by Product Manager
https://www.riskmanager.net/byn-uploads/sites/5/2020/12/Screenshot-Vortrag-Svenja.jpg 639 1145 Product Manager /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Product Manager2020-12-10 13:22:192020-12-10 13:26:08Virtuell Connected: A MEDICA 2020 Retrospective

ISO 14971:2019 – WHAT’S NEW?

News
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7. May 2020/by paulbackes
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Qware® becomes BAYOOSOFT Risk Manager

News, News
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6. November 2019/0 Comments/by paulbackes
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BAYOOSOFT Risk Manager @ MEDICA 2019

Events, Uncategorized, Uncategorized, Uncategorized, Uncategorized, Uncategorized, Uncategorized, Uncategorized, Uncategorized, Uncategorized
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18. October 2019/0 Comments/by paulbackes
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Welcome to our new website

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10. October 2019/0 Comments/by paulbackes
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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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