BAYOOSOFT Risk Manager
Core features for faultless technical documentation
Structured Work According to Lifecycle Phase
BAYOOSOFT Risk Manager offers you a project and version-based approach for managing your technical documentation. You create projects for your medical devices and can then historicize changes to your risk assessment as well as other module features in versions, depending on the device lifecycle phase or other user-defined steps. By “closing” various versions, you can ensure that certain versions can no longer be changed retroactively. You then work on subsequent versions.
This way, you transparently record the contents and results of your risk management activities and are guided through the process in a structured manner. The automatically generated documents contain your extensive information on your risk management file. The structure of BAYOOSOFT Risk Manager helps you work purposefully and efficiently as you follow the process from top to bottom in the menu tree. BAYOOSOFT Risk Manager thereby accelerates your development and approval process – allowing you to dedicate your time to the content not the process.
Medical Device Classification
Post Market Surveillance
Post-market surveillance refers to a proactive and systematic process for identifying information about medical devices already brought into circulation and for deriving necessary corrective and preventive measures.