BAYOOSOFT Risk Manager
The validated approval accelerator for conveniently generating faultless technical documentation
Overview of regulatory requirements
A sweeping range of regulatory requirements need to be observed when developing and distributing medical devices. These include international laws and ordinances, EU directives, FDA guidelines, product and process standards, guidance documents as well as a quality management system. These regulations provide the foundations for the modules and functionality of BAYOOSOFT Risk Manager:
What Our Customers Say
The foundation for the validation approval accelerator was laid with Risk 1.0 in 1998 and the solution has been continuously further developed since then. In the meantime, over 800 customers place their trust in BAYOOSOFT Risk Manager.