BAYOOSOFT Risk Manager
Event overview for the validated approval accelerator
BAYOOSOFT Risk Manager is the validated approval accelerator for conveniently generating auditable technical documentation for medical devices. The globally leading medical device manufacturer has been providing support with a process-oriented approach in the preparation of risk management documents according to ISO 14971, in usability engineering according to IEC 62366, the creation of conformity reports according to IEC 60601-1 as well as the fulfillment of the essential requirements of MDD, IVDD, MDR and IVDR since 2000. At the same time, BAYOOSOFT Risk Manager includes fully integrated requirements engineering, which significantly simplifies the traceability of requirements. For clinics and hospitals, we offer an extension module for medical IT networks according to IEC 80001-1.
The intuitive user guidance, examples provided and ready-made document templates make it easy to get started. The self-learning knowledge database results in synergy effects between projects and helps to utilize developed know-how throughout the company. At the same time, BAYOOSOFT Risk Manager meets the requirements of FDA 21 CFR Part 11.
A clear and consistent approach with the reliable application accelerates market approval and has a positive effect on expended time and costs: Our customer base of more than 800 customers reported up to 62% faster approvals for medical devices thanks to BAYOOSOFT Risk Manager.