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 Menu

News from Risk Manager

Validation of computer-based systems and software: how to make the process efficient

Editorial
Read more
30. June 2021
https://www.riskmanager.net/wp-content/uploads/sites/5/2021/06/shutterstock_1100114120-scaled.jpg 1690 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2021-06-30 15:29:322021-06-30 15:29:32Validation of computer-based systems and software: how to make the process efficient

Quality management systems – Requirements and certification according to EN ISO 13485

Editorial
Read more
23. June 2021
https://www.riskmanager.net/wp-content/uploads/sites/5/2021/06/shutterstock_344500622-scaled.jpg 1706 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2021-06-23 16:57:322023-06-29 17:30:28Quality management systems – Requirements and certification according to EN ISO 13485

BAYOOSOFT Risk Manager @T4M

Events
Read more
18. June 2021
https://www.riskmanager.net/wp-content/uploads/sites/5/2021/06/Website_Header_Inhaltsseite_ohne_Marginal_1920x320px_EN.jpg 320 1920 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2021-06-18 17:20:262023-06-29 17:29:34BAYOOSOFT Risk Manager @T4M

Kein Abkommen zwischen der Schweiz und der EU: Folgen für die Medtech-Branche

News
Read more
28. May 2021
https://www.riskmanager.net/wp-content/uploads/sites/5/2021/05/Bild_Abkommen-Schweiz-EU.jpg 720 1280 Anna Lischka /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Anna Lischka2021-05-28 08:57:292021-05-28 09:52:40Kein Abkommen zwischen der Schweiz und der EU: Folgen für die Medtech-Branche

BAYOOSOFT @DMEA 2021

Events, News
Read more
12. May 2021
https://www.riskmanager.net/wp-content/uploads/sites/5/2021/05/DMEA-Beitragsbild.jpg 720 1280 Anna Lischka /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Anna Lischka2021-05-12 10:00:392023-06-29 17:17:16BAYOOSOFT @DMEA 2021
Page 6 of 8«‹45678›»
BAYOOSOFT Risk Manager Der 3-Faktoren-Schlüssel -die Technische Dokumentation von Morgen
8. June 2023

The 3-factor key to technical documentation

Disabled female use prosthesis of hand, artificial limb, closeup. Disability, high tech medical care
10. May 2023

Classify medical devices and IVD correctly

4. April 2023

Now available: Themis Documentation Guide

IEC 80001-1 Risikomanagement und KRITIS Risiko Critis Riskmanagement
15. March 2023

Are you sure that your CRITIS is secure?

31. October 2022

BAYOOSOFT @ MEDICA 2022

Medizintechnik Klinische Bewertung
13. October 2022

Clinical Evaluation: Seamless documentation

Agile Development
10. August 2022

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

Eine Glühbirne leuchtet schwach im Vordergrund, der Hintergrund ist grau
22. July 2022

Release: BAYOOSOFT Risk Manager Version 10.5

Zwei Mens
20. July 2022

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

Mensch stapelt Holzklötze mit Symbolen aus dem Medizinbereich zu einer Pyramide
8. June 2022

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

23. May 2022

IVDR – End of the transition period

Reanimation im Krankenhaus
10. May 2022

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

Stempel
6. May 2022

BAYOOSOFT Risk Manager is DigiLab certified

Banner MedtecLIVE
25. April 2022

MedtecLIVE with T4M: Medical technology in focus

4. April 2022

BAYOOSOFT @DMEA 2022

29. March 2022

Live at medways Technology Scouting

Ein Mensch zeigt auf einen Bildschirm. In einer Hand hält er ein Stetoskop
15. March 2022

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

10. February 2022

Classification of in vitro diagnostic medical devices (IVD)

13. January 2022

The BAYOOSOFT Risk Manager 10.4 is now available

Photo by Dana Tentis from Pexels
22. December 2021

Merry Christmas 2021

16. December 2021

Usabilty Engineering – regulatorische Anforderungen und die IEC 62366

9. November 2021

The whole world of medicine: BAYOOSOFT @Medica 2021

3. September 2021

Digital statt analog – eine Vortragsreihe von BAYOOSOFT

18. August 2021

BAYOOSOFT Risk Manager 10.3 – available now

28. July 2021

Software development according to IEC 62304: Which requirements do you have to fulfil?

30. June 2021

Validation of computer-based systems and software: how to make the process efficient

23. June 2021

Quality management systems – Requirements and certification according to EN ISO 13485

18. June 2021

BAYOOSOFT Risk Manager @T4M

28. May 2021

Kein Abkommen zwischen der Schweiz und der EU: Folgen für die Medtech-Branche

12. May 2021

BAYOOSOFT @DMEA 2021

15. April 2021

2nd Virtual Edition MedtecLIVE & SUMMIT

2. March 2021

Happy Birthday, BAYOONET

8. February 2021

The Hospital Future Fund: Funding for IT Security

13. November 2020

BAYOOSOFT Risk Manager @ MEDICA 2020

5. October 2020

CRITIS-Crux at hospitals

17. August 2020

Partnership with HEX Approach

Blogbeitrag Risk Manager Release10
31. July 2020

The new version 10 of BAYOOSOFT Risk Manager

7. May 2020

ISO 14971:2019 – WHAT’S NEW?

6. November 2019

Qware® becomes BAYOOSOFT Risk Manager

18. October 2019

BAYOOSOFT Risk Manager @ MEDICA 2019

Interesting links

Here are some interesting links for you! Enjoy your stay :)

Pages

  • Blog
  • Company
  • Contact
  • Contact support
  • Customer Center
  • Customer Voices
  • Digital flyer
  • Edit profile
  • Features
  • Forum
  • Landingpage Medica 2020
  • Legal
  • Login
  • Medical Device Regulation Clinical Evaluation
  • Medical electrical equipment IEC 60601-1
  • Medical IT networks according to IEC 80001-1
  • Modules
  • Modules & Features
  • Newsletter Unsubscribe
  • Privacy Policy
  • References
  • Reset password
  • Services
  • Solution
  • Special precautions for IT networks according to ISO 80001
  • Start
  • Test Now
  • The Validated Approval Accelerator
  • Upcoming Events

Categories

  • BAYOOSOFT Themis
  • Editorial
  • Events
  • News
  • Releases
  • Uncategorized
  • Privacy Policy
  • Legal
Scroll to top