Technical documentation reimagined
Technical documentation rethought – efficient and compliant with standards
BAYOOSOFT Themis provides you with a validated solution for the technical documentation of medical devices as well as for documentation processes for quality and information security management systems. With our software, you can digitize and link your processes, reduce effort and minimize redundant data. This allows you to optimize your technical documentation in accordance with MDR and IVDR, while at the same time ensuring efficient and compliant management of your documents. Our specialized modules cover all relevant requirements for medical devices and management systems – from risk assessment and technical documentation to compliance with international standards and regulations such as MDR, IVDR and quality and information security standards.
Efficient technical documentation of medical devices according to MDR and IVDR
While regulatory requirements, particularly in the area of technical documentation, are constantly increasing, the world of work is becoming increasingly volatile. Issues such as collaboration, growing teams and cross-location working are indispensable components of the corporate world today. How can you reduce effort and costs at the same time? With BAYOOSOFT Themis, the validated and standard-compliant solution for increasing regulatory productivity. How it works: BAYOOSOFT Themis digitizes your technical documentation processes and accelerates them through central management and the linking of individual information units. Not only individual tasks, but complete process chains are optimized. This significantly reduces the use of resources and error rates compared to manual processing. In this way, operational expenses, for example when updating existing files, can be sustainably reduced. At the same time, the acceptance and quality of the documentation created is improved and compliance with MDR and IVDR requirements is ensured.
Optimized process management with ISMS and quality management software
BAYOOSOFT Themis also offers integrated quality management software for compliance with standards such as ISO 13485, which ensures continuous improvement of your processes. The software facilitates quality management by supporting audits and ensuring the traceability of all processes. In addition, the ISMS module integrated in BAYOOSOFT Themis ensures maximum data security. In accordance with ISO 27001, it protects your sensitive data from unauthorized access and guarantees compliance with strict data protection guidelines. This is crucial for the secure handling of confidential information in the context of technical documentation. The modular structure of BAYOOSOFT Themis enables flexible adaptation to your specific requirements. Whether you need support with risk assessment, the classification of medical devices or the implementation of international standards – our software offers you the right solution.
The BAYOOSOFT Themis modules
Features for efficient technical documentation and digital quality management
With BAYOOSOFT Themis, you can further optimize your technical documentation and improve collaboration in your projects with modern tools and digital processes. The BAYOOSOFT solution focuses on optimizing teamwork, increasing efficiency through comprehensive digitalization and offers precise monitoring for seamless tracking of your projects.
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