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.
Increase your regulatory productivity and create the Technical Documentation of your Medical Device & In-Vitro Diagnostics in a structured and consistent manner.
With the electronic reference work MEDiLEX for the European legaislation on Medical Devices and In-Vitro Diagnostics, you will constantly stay up to date with the latest regulatory information.
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.
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This is what BAYOOSOFT’s own software solutions accomplish. Since 2001, BAYOOSOFT has been successful in creating turnkey software solutions. Designed as management software, the solutions focus on highly regulated areas and critical infrastructures. Building on many years of experience, we are familiar in detail with the special needs and requirements associated with increasing flexibility and optimization of IT processes. For companies, we achieve added value that gives them a lasting competitive advantage, and we are proud that our customers continually acknowledge this.
With enthusiasm the BAYOOSOFT team designs and markets a comprehensive product portfolio. Our quality management processes according to ISO 9001, certified by TÜV Hessen, are an expression of our passion for sustainable business solutions and strong customer focus.
Our highly qualified team works on-site at our headquarters in Darmstadt as well as at our locations in Munich, Berlin and Cologne. We do not outsource any work to other companies, such as in the IT near- or offshoring sector. All of our co-thinkers are personally contactable, and your personal solution engineer can also support you directly on site if desired and required.