We are always able to be close to the needs of users with our software – not only thanks to our positive dialog with our customers but also collaboration with our partners. We maintain particularly intensive contact with our gold partners. You can get in touch with them for content-related questions regarding approval and CE marking, risk management for your medical devices in general or questions concerning usability engineering.
Management software for strongly regulated sectors and critical infrastructure
BAYOOSOFT GmbH – since 2001 part of the BAYOOSOFT Group based in Germany – is an expert for management software. The focus of our solutions lies on strongly regulated sectors and critical infrastructures. Our quality management processes are certified by TÜV Hessen in accordance with ISO 9001 are an expression of our passion for sustainable company solutions and distinct customer focus. We are the manufacturers of BAYOOSOFT Risk Manager – the validated approval accelerator for generating faultless technical documentation for medical devices – and BAYOOSOFT Access Manager – the solution for automated authorization management.
BAYOOSOFT Risk Manager is the validated approval accelerator for conveniently generating auditable technical documentation for medical devices. For over 18 years, 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. 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.
Development and support for our software solutions are performed exclusively in Germany by our qualified employees.
Besides BAYOOSOFT, other specific business units exist to fulfill the individual needs and requirements of our customers:
BAYOOMED Medical Software
Specialized in medical software and medical apps
BAYOOTEC Enterprise Software
Specialized in the development of CMS-supported web applications, e-commerce suites, apps and desktop applications in the enterprise segment
Get to Know Our Partners
Our GOLD Partners
Solutions for medical technology
Dynamic, secure and economic
Metecon is your specialist for reviewing and testing, as well as for the documentation and approval of medical devices. Our know-how in technical documentation, test design, verification and clinical evaluation ensure the fast, secure and cost-efficient development of your medical device.
How do we achieve this? By keeping the end goal in mind from the very beginning. We plan intensively at the start of the project in order to coordinate all aspects of testing and documentation efficiently with your development process and consider the regulatory requirements on your product at all times. We identify potential project errors at an early stage, saving lots of time and money in resolving them at a later stage. This is how we pave the way for your product’s success from the start of the project.
Specialization, experience and competence
Achieve your goal with our experience!
Jörg Stockhardt consulting & more has been supporting manufacturers and distributors of medical devices and in-vitro diagnostics on their path to distribution and certification since 1991.
We pursue one goal above all with our experience, care and reliability: your trust. After all, any successful consulting service revolves around the certainty of identifying all parameters and creating the best possible conditions for a smooth process.
Whether you are seeking CE marking, FDA approval, quality or risk management – we can assist you throughout the entire project from beginning to end. And this not only applies to consulting: We also prepare documentation and train your staff upon request.
Shaping Interaction
We design, optimize and implement unique user interfaces for enterprise, industrial and medical applications, as well as for mobile devices and consumer products.
Our team of UX specialists develop elegant and smart solutions distinguished by simple, intuitive interaction and an excellent user experience. Thanks to their analytical competency and creativity, our employees create innovative user interfaces that inspire users and customers.
Custom Medical offers you longstanding project experience, extensive industry knowledge and a proven, user-centric approach. We also consider long-term project visions and assume responsibility towards customers, employees and business partners.
You too can become a partner of BAYOOSOFT Risk Manager
We emphasize our passion for sustainable company solutions and distinct customer focus through partnerships with selected advisors. Our partners benefit from valuable support and attractive conditions from the very first customer project.