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
About
Felix Blaschke
This author has not written his bio yet.
Entries by Felix Blaschke
Nothing Found
Sorry, no posts matched your criteria
Scroll to top