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
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BAYOOSOFT Risk Manager

Modules & Features at a Glance

BAYOOSOFT Risk Manager has been the globally leading and validated software solution for preparing technical documentation for manufacturers of medical devices and in-vitro diagnostics since 2000.

BAYOOSOFT Risk Manager is a software solution validated according to GAMP 5, which guides you through the standard requirements in a structured way, also using illustrative examples provided. You are automatically shown smart suggestions at relevant points thanks to the self-learning knowledge database included in the basic module. In this way, the application automatically analyzes all documents ever created with BAYOOSOFT Risk Manager in your company in real time – as you enter text – and recognizes whether other hazards or causes were identified with other similar products in the past, or whether measures were implemented which you have not yet considered with the current product. With its efficiency calculator, BAYOOSOFT Risk Manager also determines which measures could be particularly efficient, for example, and presents you these suggestions accordingly.

  • Tried and tested solution since 2000

  • Current regulatory requirements

  • Cross-project knowledge transfer

  • Process-oriented user guidance

  • Focus on content aspects

  • Prevention of redundant data

  • Work efficiently with automation

  • Generate auditable documents at the press of a button

  • FDA 21 CFR Part 11

  • Validated according to GAMP 5

Core functionalities of BAYOOSOFT Risk Manager

These key features provide the foundations for conveniently generating technical documentation for medical devices. Find out more:

Preliminary hazard analysis

Failure mode and effect analysis

Structured work according to lifecycle phase

Medical device classification

Post-market surveillance

Fine-grained authorization management

Visualizing with the grey box

Module Overview

Click to find out more about the individual modules:

  • Risk Management

    DIN EN ISO 14971

  • Usability Engineering

    EN 62366 & EN 60601-1-6

  • Essential Requirements

    MDR 2017/745 & IVDR 2017/746

  • Medical Electrical Equipment

    IEC 60601-1

  • Requirements Engineering

    Requirements, test cases and traceability

  • Clinical Evaluation

    MDR 2017/745 & MEDDEV 2.7.1 rev4

  • REST API

    Integration into the system landscape

  • Medical IT Networks

    IEC 80001-1

  • Advanced Reporting

    Individual report adjustments

  • Pre-Validation Package

    Software validation according to ISO 13485:2016

News

  • BAYOOSOFT @ MEDICA 202231. October 2022 - 18:52
  • Medizintechnik Klinische BewertungClinical Evaluation: Seamless documentation13. October 2022 - 13:32
  • Agile DevelopmentAgile IEC 62304: How you can use the standard in the development process10. August 2022 - 16:56
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 – 0
Fax: +49 (0) 6151 – 86 18 – 150

Contact: [email protected]
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