In 1998, the foundation for conveniently generating technical documentation was laid with Risk 1.0. To prepare this documentation reliably and in compliance with standards, the focus continues to lie on risk management according to EN ISO 14971. It is continuously expanded with further standards such as usability engineering according to IEC 62366, preparation of the conformity report according to IEC 60601-1 or fulfillment of the essential requirements of MDD, IVDD, MDR and IVDR. Moreover, the validated approval accelerator now includes fully integrated requirements engineering, which significantly simplifies the traceability of requirements. Clinics and hospitals also benefit from an extension module for medical IT networks according to IEC 80001-1.
Besides the global market leader for the technical documentation of medical devices, we offer BAYOOSOFT BAYOOSOFT Access Manager (formerly Fileserver Management Suite) – the software solution for the automated authorization management of file servers, SharePoint, Active Directory and third-party systems.
Both solutions focus on strongly regulated sectors and critical infrastructures and are now therefore newly positioned under BAYOOSOFT.
Following this continuous development, Qware® Riskmanager has now been renamed to BAYOOSOFT Risk Manager and received a new logo: