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
      • biotrics bioimplants AG: Enrichment of the approval process by BAYOOSOFT Risk Manager
      • Selection from Our Customer List
      • Continuous Development since 1998 – Version History
  • 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
      • Upcoming Events
      • Test Now
      • Contact Request
  • Company
    • Company
      • About us
      • We think proactively
    • Our Partners
      • Get to know Our Partners
      • Become Partner now
  • Blog
  • Upcoming Events
  • Test Now
  • Customer Center
  • Search
  • Menu

The 3-factor key to technical documentation

BAYOOSOFT Themis, Editorial
Read more
8. June 2023/by Anna Lischka
https://www.riskmanager.net/wp-content/uploads/sites/5/2023/05/BAYOOSOFT-Risk-Manager-Der-3-Faktoren-Schluessel-die-Technische-Dokumentation-von-Morgen.jpg 1200 1800 Anna Lischka /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Anna Lischka2023-06-08 06:00:182023-06-01 12:31:50The 3-factor key to technical documentation

Classify medical devices and IVD correctly

BAYOOSOFT Themis, Editorial
Read more
10. May 2023/by Julia Pfeffinger
https://www.riskmanager.net/wp-content/uploads/sites/5/2023/05/Prosthesis-of-hand-artificial-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2023-05-10 14:49:002023-05-10 14:49:00Classify medical devices and IVD correctly

Are you sure that your CRITIS is secure?

Editorial
Read more
15. March 2023/by Julia Pfeffinger
https://www.riskmanager.net/wp-content/uploads/sites/5/2023/03/IEC-80001-1-Risikomanagement.png 1080 1920 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2023-03-15 14:04:242023-03-15 14:04:24Are you sure that your CRITIS is secure?

Clinical Evaluation: Seamless documentation

Editorial
Read more
13. October 2022/by Julia Pfeffinger
https://www.riskmanager.net/wp-content/uploads/sites/5/2022/10/shutterstock_381068455-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-10-13 13:32:472022-10-13 13:32:47Clinical Evaluation: Seamless documentation

Agile IEC 62304: How you can use the standard in the development process

Editorial
Read more
10. August 2022/by Julia Pfeffinger
https://www.riskmanager.net/wp-content/uploads/sites/5/2022/08/MedizintechnikNL-SOFT-scaled.jpg 1463 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-08-10 16:56:532022-08-17 16:57:08Agile IEC 62304: How you can use the standard in the development process

General safety and performance requirements: What applies to medical devices under MDR and IVDR?

Editorial
Read more
20. July 2022/by Julia Pfeffinger
https://www.riskmanager.net/wp-content/uploads/sites/5/2022/07/shutterstock_1895104081-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-07-20 18:22:072022-07-20 18:22:07General safety and performance requirements: What applies to medical devices under MDR and IVDR?

Risk management in the development process of medical devices: Beginning and end?

Editorial
Read more
8. June 2022/by Julia Pfeffinger
https://www.riskmanager.net/wp-content/uploads/sites/5/2022/06/Header-RM.jpg 720 1280 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-06-08 16:42:322022-06-10 09:08:50Risk management in the development process of medical devices: Beginning and end?

Hazards and risks: This applies in risk management for medical devices

Editorial
Read more
10. May 2022/by Julia Pfeffinger
https://www.riskmanager.net/wp-content/uploads/sites/5/2022/05/shutterstock_129913760-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-05-10 09:11:572022-06-10 09:21:58Hazards and risks: This applies in risk management for medical devices

How is the classification of medical devices according to MDR carried out?

Editorial
Read more
15. March 2022/by Julia Pfeffinger
https://www.riskmanager.net/wp-content/uploads/sites/5/2022/03/shutterstock_519284317-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-03-15 17:24:542022-03-16 11:55:23How is the classification of medical devices according to MDR carried out?

Classification of in vitro diagnostic medical devices (IVD)

Editorial
Read more
10. February 2022/by Julia Pfeffinger
https://www.riskmanager.net/wp-content/uploads/sites/5/2022/02/shutterstock_524351890-scaled.jpg 1536 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-02-10 10:11:132022-02-10 10:11:13Classification of in vitro diagnostic medical devices (IVD)
Page 1 of 212

News

  • BAYOOSOFT Risk Manager Der 3-Faktoren-Schlüssel -die Technische Dokumentation von MorgenThe 3-factor key to technical documentation8. June 2023 - 6:00
  • Disabled female use prosthesis of hand, artificial limb, closeup. Disability, high tech medical careClassify medical devices and IVD correctly10. May 2023 - 14:49
  • Now available: Themis Documentation Guide4. April 2023 - 19:04
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 – 700
Fax: +49 (0) 6151 – 86 18 – 150

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

  • Privacy Policy
  • Legal
Scroll to top