BAYOOSOFT offers BAYOOSOFT Themis, the validated and standard-compliant solution for increasing regulatory productivity, in order to keep workload and costs as low as possible despite increasing requirements from laws, guidelines and standards for manufacturers of medical devices and in-vitro diagnostics. It digitizes the processes for creating technical documentation and accelerates the evaluation of the impact of changes by centrally managing and linking individual information units. Not only individual tasks, but entire processes are thus optimized, which means that the use of resources and error rates are far lower than with manual processing. This allows you to sustainably reduce operational costs, e.g. when updating existing files, while at the same time increasing the acceptance of the files created by the designated bodies.
The efficient and standard-compliant approach is rounded off by a self-learning knowledge database, with which the acquired knowledge grows continuously and across projects. The information is made available to your authorized employees throughout the company and frequently recurring elements are provided for the creation of new documentation.
Documentation Guide
Which documents must be submitted to the notified body for approval? What is the current status of the information supplied? Who is currently working on it and what do you still need to approve?
Do you ask yourself questions like these every day? Get transparency and an overview with the Themis Documentation Guide.
New requirements
As regulatory requirements continue to rise, the world of work is becoming increasingly volatile. Issues such as collaboration, growing teams and cross-location working are now commonplace in the world of medical device manufacturers.
Rethinking technical documentation
This is precisely why BAYOOSOFT Themis is reshaping the path of technical documentation – holistically, innovatively, individually and globally.
Risk Manager
Medical devices involve risks and therefore require a high level of protection. Risk management for medical devices and in-vitro diagnostics is prescribed in German, European and American regulations.
The ISO 14971 standard defines a procedure for the identification, assessment and control of risks associated with medical devices. These requirements apply throughout the entire product life cycle.
Automated risk management
BAYOOSOFT Themis records all relevant information in a structured manner, stores it in an audit-proof manner and links it dynamically. You can base your risk management on FMEA or PHA. Integrated project and version management, action management, risk inventory with automatic reminders and self-learning template management make the process much easier and faster.
Standard-compliant
BAYOOSOFT Themis is the world’s leading software for the creation of risk management files according to ISO 14971 and fulfills the requirements of FDA 21 CFR Part 11.
Device Validation Manager
The DIN EN 62366 standard obliges manufacturers of medical devices to carry out and document a usability engineering process. This not only fulfills legal requirements, but also becomes an important sales factor, as it reduces the risk of operating errors and increases user acceptance.
BAYOOSOFT Themis fully integrates the usability engineering process into risk management in accordance with ISO 14971. With a tried-and-tested structure, it guides you through all the necessary steps up to the usability engineering file in accordance with DIN EN 62366 and IEC EN 60601-1-6. This includes the definition of usage conditions, user groups, usage scenarios, validation plans and verification methods such as usability tests and expert reviews. This covers all the requirements of the standards and significantly speeds up work processes.
Requirements Engineer
Requirements engineering is crucial for the error-free development of complex medical systems, especially in the case of complex product concepts and development based on division of labor. It includes the definition and implementation of processes as well as the traceability of all requirements over the entire product life cycle.
BAYOOSOFT Themis fully integrates requirements engineering into the regulatory process. Measures automatically become new requirements, traceability is ensured across different documents, and requirements are validated and verified. Usability-relevant requirements are integrated into the usability engineering process, avoiding duplicate data entry.
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