When we talk to experts in the field of product management of Medical Devices / In-Vitro-Diagnostics and Regulatory Affairs, one thing emerges clearly: Many standard processes around the generation of the Technical Documentation for Medical Devices / In-Vitro-Diagnostics and management of the Risk File are done manually. In doing so unnecessary time and costs are used.
Therefore, it is part of our mission to support Medical Device / In-Vitro-Diagnostics manufacturers with digitizing those processes. In order to ensure successful and resource-optimized implementation, we rely on the best-of-breed strategy, which ideally meets the requirements of these highly regulated processes. In more than 23 years over 3.500 risk files have been generated successfully with BAYOOSOFT solutions and Medical Devices have been brought 62% faster to market.
What our customers say
I highly recommend BAYOOSOFT to anyone who needs to create a comprehensive Risk Management File.
Especially for manufacturers of medical electrical equipment, BAYOOSOFT Risk Manager is the number one choice from my point of view. I highly recommend it to everyone!
BAYOOSOFT Risk Manager allowed us to bypass the time-consuming manual work. The software guides us through the process flawlessly, you can’t deviate, you can’t forget anything, and you get a impeccable result.