Efficient quality and ISMS software for maximum security

eMS QMSeMS ISMS

With BAYOOSOFT Themis Management Software, we offer you a comprehensive solution for quality management (QM) and information security management (ISMS). A certified QM/ISMS is important proof to customers and regulatory authorities that your company is taking all the necessary steps to ensure the security and effectiveness of the products it develops.

Implementing this management software not only increases the efficiency of your processes, but also minimizes risks such as recalls and liability claims. This not only ensures your compliance, but also the trust of your partners and customers.

BAYOOSOFT Themis - Management Software - ISMS & QMS

Optimized management software for quality and information security management systems

BAYOOSOFT Themis offers a validated solution for the documentation processes in quality management systems (QMS) and information security management systems (ISMS). By digitizing your processes, you reduce the documentation effort in the long term and minimize redundant data. A management system is a structured framework that supports your company in organizing, controlling and continuously improving business processes.

The central components here are

  • Definition of roles and their responsibilities
  • Defining rules and processes to achieve specific corporate goals
BAYOOSOFT Themis Management Software - ISMS und QMS

Management software for ISO 27001, ISO 9001 and ISO 13485 compliance

This management software increases your efficiency, creates competitive advantages and ensures compliance with legal regulations. With the Management Systems Pack from BAYOOSOFT, you can not only implement these management systems, but also continuously improve them.

The software supports you in creating, monitoring and optimizing your management systems by leveraging the synergies between different standards, significantly reducing the administrative burden. This means you can manage complex requirements in one integrated system while maximizing the efficiency of your processes.

ISO 27001

ISO 9001

ISO 12485

Teamwork

Thanks to multi-user capability, colleagues can enter content and results in parallel in the same document and are guided through the process in a structured manner. By labeling and assigning open and processed tasks, team dashboards, notifications, chats and comments, you can easily and quickly exchange information within the team – even across multiple locations.

Digitization

All relevant information is recorded in a clearly structured environment and dynamically linked with one another at a fine granular level. The knowledge database creates cross-project synergy effects and promotes the company-wide use of the acquired know-how. The structure of the knowledge platform and structured templates enable documentation processes to be carried out efficiently and securely.

Compliance

The approval of your product by Notified Bodies depends crucially on conformity with the required directives, norms and standards.
Our software solution creates complete and standard-compliant technical documentation from your data and guides your team efficiently through all the necessary processes, even if team members have no previous experience.

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What our customers say

Dr. Robert Zinke, biotrics

Dr. Robert Zinke, biotrics

At BAYOOSOFT, I really appreciate how quickly and thoroughly I am helped as a customer. Good software is one thing, but if I don’t have a contact person when I have questions, even the best software is useless.

Lucas Greulich, LIKAMED

Lucas Greulich, LIKAMED

You can see that BAYOOSOFT’s software solutions are constantly being developed for users and feedback is implemented. The team comes to us at regular intervals and asks us directly what could be improved.

Documentation Guide

Which documents have to 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 have to release?

You ask yourself questions like these every day? Gain transparency and get an overview with the Themis Documentation Guide.

New requirements

As regulatory requirements continue to rise, the world of work is becoming increasingly volatile. Topics such as collaboration, growing teams and working across locations 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.

BAYOOSOFT Themis - Technische Dokumentation neu gedacht

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.

Documentation Guide

ISO 13485, ISO 9001, ISO 27001

Process Packs

Management Systems

OR

Themis Ultimate

All Documentation Guides + Process Packs + all Technical Documentation options

Svenja Winkler
CEO

How to contact us

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