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
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IVDR – End of the transition period

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23. May 2022/by Anna Lischka
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BAYOOSOFT Risk Manager is DigiLab certified

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6. May 2022/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2022/05/digilab_Stempel_RGB_300dpi.jpg 768 886 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-05-06 09:24:572022-05-09 15:35:55BAYOOSOFT Risk Manager is DigiLab certified

BAYOOSOFT Risk Manager 10.3 – available now

Releases
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18. August 2021/by Julia Pfeffinger
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Kein Abkommen zwischen der Schweiz und der EU: Folgen für die Medtech-Branche

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28. May 2021/by Annika Pörner
https://www.riskmanager.net/byn-uploads/sites/5/2021/05/Bild_Abkommen-Schweiz-EU.jpg 720 1280 Annika Pörner /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Annika Pörner2021-05-28 08:57:292021-05-28 09:52:40Kein Abkommen zwischen der Schweiz und der EU: Folgen für die Medtech-Branche

BAYOOSOFT @DMEA 2021

Events
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12. May 2021/by Annika Pörner
https://www.riskmanager.net/byn-uploads/sites/5/2021/05/DMEA-Beitragsbild.jpg 720 1280 Annika Pörner /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Annika Pörner2021-05-12 10:00:392021-05-19 08:49:54BAYOOSOFT @DMEA 2021

Happy Birthday, BAYOONET

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2. March 2021/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2021/03/shutterstock_63832522_Zuschnitt-scaled.jpg 1338 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2021-03-02 14:53:432021-03-02 14:53:43Happy Birthday, BAYOONET

The Hospital Future Fund: Funding for IT Security

Editorial, Uncategorized
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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

CRITIS-Crux at hospitals

Editorial, News, News, News, News, News, News, News, News, News, News
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5. October 2020/by paulbackes
https://www.riskmanager.net/byn-uploads/sites/5/2020/10/Beitragsbild.png 925 1173 paulbackes /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png paulbackes2020-10-05 09:56:132020-10-14 09:56:29CRITIS-Crux at hospitals

Partnership with HEX Approach

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17. August 2020/by paulbackes
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The new version 10 of BAYOOSOFT Risk Manager

Releases
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31. July 2020/by paulbackes
https://www.riskmanager.net/byn-uploads/sites/5/2020/07/Release-10.png 425 1400 paulbackes /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png paulbackes2020-07-31 13:48:512020-08-19 16:10:04The new version 10 of BAYOOSOFT Risk Manager
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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

BAYOONET AG
Europaplatz 5
D-64293 Darmstadt

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

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