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
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      • Medical device classification
      • Software Validation – Your Service Options
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Contacts at BAYOOSOFT 

Svenja Winkler
CEO
[email protected]

 

 

Franziska Weiß
Head of Sales [email protected]

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