In addition to the option of generating a zip report with individual task reports as usual, the user will also be able to generate an overall report with all task reports as one PDF file. 

The new report elements (please see “Additional non-content reports”) can also be included.

Overall Report

you as a manufacturer  of medical devices to carry out a usability engineering process and document it in a usability engineering file. In doing so, not only do you fulfill the legal requirements, usability is also increasingly becoming a decisive sales factor. Implementing usability measures reduces the risk of operating errors for users, patients and third parties. At the same time, integrating representative  users into the development process ensures a high level of acceptance for your product among your target group.

Support formative and summative Usability Evaluations

Based on your feedback we are working on providing additional report components, such as cover page, introduction page, statement page and header/footer.
These components will be configurable.

Additional Report Components

We are planning to introduce configurable table view reports to enable users to create personalized reports by configuring table views according to the specific needs within the project. Users will be able to:

Configurable table view within the system and for reports

Document approval is a critical business process involving editing, review and authorization (approval) of documents before they are finalized and put into effect. This process is fundamental across various sectors and for a multitude of document types. The traditional approach to document approval is manual, often involving physical documents passed from one approver to another. It often takes place after the actual edit and review process and therefore causes additional time and effort. 

I as a person who is involved in such approval process would like to have this processes connected to the actual task status: If a user changes the status of a task in BAYOOSOFT Themis this shall be documented with user, date and time as one step of my approval documentation.

Approval Workflow for Technical Documentation

Within our organization a lot of standards & regulations apply to one or more projects. 

Our Notified Body requests a list of standards & regulations (named: 

Additionally, when a new version of a standard & regulation is released, we would like to know, which projects need to be checked and adapted. Also it would be great to adapt all references with just editing a single entry.

LAS - List of Applied Standards

Allow to answer Essential Principles of the Australian Therapeutic Goods (Medical Devices) Regulations 2002 together with General Safety and Effectiveness Requirements of the European Regulations for Medical Devices and In-Vitro-Diagnostics

MDSAP Australia - Essential Principles

There are some tasks in TD Guide which are required 1:1 in Risk Management Plan module (and other modules like Clinical Evaluation Plan, Usability Engineering Plan etc) as well, e.g. those are:

As a editor of Technical Documentation I would like to avoid redundancies in these information as those cause high risk in not getting my Medical Device approved by the Notified Body: Often if one of those tasks is updated, all the other places (or only some) are forgotten to be updated and thus my documentation is inconsistent.

Avoid redundancies in documentation

It is planned to provide a comprehensive guidancy system to assist manufacturers of Medical Electrical Equipment on navigating the extensive IEC 60601-1 standard. This will provide a step-by-step instruction and contextual help for each requirement, ensuring to fulfill them in less time:

Checklist for IEC 60601-1 (Medical Electrical Equipment; MEE)

IT departments want to provide a seamlessly log in to provided tools using their internal company credentials. By implementing Single Sign-On (SSO) with LDAP/AD/Azure, we enable customers to securely and easily log in with their existing corporate credentials without having to manage separate credentials for our tool.

This makes it easier for users to access our tool and significantly improves the user experience as they do not have to remember additional credentials. In addition, SSO provides greater security as authentication is done through the company's internal systems, reducing the risk of security breaches due to weak or stolen passwords.

Single Sign On using LDAP/AD/Azure

Allow to answer Safety and Effectiveness Requirements of the Canadian Medical Devices Regulations (SOR/98-282) together with General Safety and Effectiveness Requirements of the European Regulations for Medical Devices and In-Vitro-Diagnostics

MDSAP Canada - Safety and Effectiveness Requirements

This function increases the efficiency of workflows, because approval workflows or documents no longer have to be physically printed out and signed. 

Now, everything can be done conveniently and quickly online. In addition, the digital signature improves the security of documents. It guarantees authenticity and integrity.

At any time, it is possible to trace who signed a document and when, which increases transparency within the processes. The digital signature also supports compliance with legal requirements, as it is legally recognized and therefore fulfils the documentation requirements.

Digital Signature

As a manufacturer of medical devices, I want to have several versions of basically the same product on the market. Each product version has several versions of its documentation. There can only be one version of the documentation that is being worked on, because we can only release one documentation anyway and editing in multiple versions comes with the risk of losing changes.

Module Versioning & Version Approval

As a manufacturer of medical devices, it is essential to ensure that my products comply with the General Safety and Performance Requirements (GSPR) for the Medical Device Single Audit Program (MDSAP) Brazil. Compliance with these GSPRs reduces the risk of operational errors for users, patients and third parties.

The standards for the Medical Device Single Audit Program (MDSAP) Brazil provide a clear guide to lead me through the process of GSPR compliance. I am looking for a solution that will allow me to manage this process efficiently and ensure that my products comply with Brazilian regulations by enabling comprehensive planning and documentation of my compliance actions.

Allow to answer Safety and Effectiveness Requirements of the Brazilian Good Manufacturing Practices (RDC No 848-06:2024) together with General Safety and Effectiveness Requirements of the European Regulations for Medical Devices and In-Vitro-Diagnosticsd Performance of Medical Devices.

GSPR for MDSAP Brasil

The internationally valid standard ISO 14971 stipulates a procedure which identifies, assesses, rates and controls hazards associated with medical devices and their accessories, and monitors the effectiveness of these 
controls. The requirements of this standard on risk management shall be fully integrated in BAYOOSOFT Themis for preparing compliant risk management documents. The procedure follows a clearly structured approach based on the process steps of the standard.

Preliminary Hazard Analysis acc. ISO 14971

for your Medical Device and 
hence approval for distribution in Europe, it’s necessary to comply with General Safety and Performance Requirements of MDR 2017/745 and IVDR 2017/746,


With the help of an interactive checklist, the requirements are filtered according to your medical device, meaning you only need to answer the relevant questions. This enables you to benefit from time savings in reviewing the essential requirements, while you keep the technical documentation at the same assessment level consistently.

Interactive Checklist for GSPR (MDR & IVDR)

Allow to answer Essential Principles of Safety and Performance of Medical Devices in Japan together with General Safety and Effectiveness Requirements of the European Regulations for Medical Devices and In-Vitro-Diagnostics

MDSAP Japan - Essential Principles

The ISO standards that are related to quality or information management systems (e.g. ISO 27001, ISO 13485, ISO 9001) often make the same requirements for management processes, e.g. 

When establishing a Management System organizations often start with fulfilling requirements of a single standard. Sometimes, in a later stage it is required to additionally fulfill requirements of other standards as well. In this case the first step is to map the requirements of the standard. This helps in identifying which requirements still need to be fulfilled and which ones are already fulfilled. Normally, this is done in big Excel files and takes a lot of effort in the QM-team.

Therefore, I as a user of more than one ISO Guidance I would like to be provided with a mapping of similar requirements so that I am able to save time in adding additional standards to my QMS/ISMS.

Mapping of ISO Guidances

Allow to answer Safety and Effectiveness Requirements of the FDA QSR – 21 CFR Part 820 together with General Safety and Effectiveness Requirements of the European Regulations for Medical Devices and In-Vitro-Diagnostics

MDSAP USA - Safety and Effectiveness Requirements

With the integration of a global glossary of terms and definitions, team members will have access to a centralized list of terms, ensuring consistent usage and understanding. Linked terms within tasks will provide instant access to definitions, reducing ambiguity and improving efficiency. 

Glossary - List of Terms & Definitions

Based on your feedback the following improvements will be made on reports generated from BAYOOSOFT Themis:

Report Improvements

Performing information security risk assessments at planned intervals or when significant changes are proposed or occur as well as implementing a risk treatment plan is one of the major requirements of an ISMS. The ISO 27005 provides guidance on how to implement the information security risk requirements and contains a detailed guidance on a risk management process.

BAYOOSOFT Themis shall provide modules to perform a risk analysis according to this ISO standard.

Risk Analysis according to ISO 27005

Besides the management, review and approval of Technical Documentation Manufacturers of Medical Devices and In-Vitro-Diagnostics do have lots of activities related to their quality management system. 

We are considering if it is helpful for Manufacturers manage SOPs and Work Instructions as well has enabling all employees with a read only functionality to see released QM documents.

Digital QMS/ISMS

IEC 80001-1 is directed at all IT network operators who run at least one medical device in their network. In particular, this standard requires risk management throughout the entire lifecycle of the IT network, i.e. for as long as the medical device is part of the network.

BAYOOSOFT Themis will offer you to fulfill these regulatory requirements on risk management. Plan and document your IT networks with the software module: Risk Management According to IEC 80001-1. This allows you to take care of all requirements, manufacturers, network components, changes and monitoring in a central place.

Risk Management acc. IEC 80001-1 (IT-Networks)

Which SOPs are fulfilling which requirement of the IEC 27001? What is the current status of implementing those requirements? Who is currently working on it and what still needs to be considered in this QMS release? 

Users shall achieve transparency and get a comprehensive overview of all IEC 27001 requirements.

Guidance for ISO 27001

 To minimize the risks of cyber attacks, data loss and other security threats, it is essential to establish and maintain an information security management system (ISMS). By conducting a structured survey of the IT status, determining the need for protection and implementing the appropriate security measures, the organization can be independently audited and certified.

Which protective measures result from the structural analysis of the current state of IT? When is an explicit risk analysis necessary? BAYOOSOFT Themis will support you in those activities according to BSI Grundschutz and guides you in a structured way through the process.

Risk Analysis according to BSI Grundschutz

Which SOPs are fulfilling which requirement of the DIN EN ISO 9001? What is the current status of implementing those requirements? Who is currently working on it and what still needs to be considered in this QMS release? 

Users shall achieve transparency and get a comprehensive overview of all ISO 9001 requirements.

Guidance for ISO 9001

Connect our software solution BAYOOSOFT Themis with the market leading software solution for Risk Management, Usability Engineering and Clinical Evaluation.

Integrate Themis Documentation Guide in Risk Manager

IEC 62304 applies to the development and maintenance of medical device software if the software itself is a medical device or an embedded or integral component of a finished medical device. It stipulates that the medical device software must be developed and maintained within a risk management system. This means, for example, that software requirements must be considered as part of risk analysis. At the same time, it is important to ensure 
that effective measures are considered in the software requirements.

BAYOOSOFT Themis will support those requirements of IEC 62304 by allowing to manage requirements and tests and create a traceability matrix.

Software Lifecycle Process acc. IEC 62304

Often root cause analysis of hazards is performed using the failure mode and effect analysis (FMEA). Linking the FMEA activities with elements from PHA (Preliminary Hazard Analysis) allows to make those relations transparent and easy to switch between the files.

Allow to combine multiple Risk Analysis for one project

Which SOPs are fulfilling which requirement of the DIN EN ISO 13485? What is the current status of implementing those requirements? Who is currently working on it and what still needs to be considered in this QMS release? 

Users shall achieve transparency and get a comprehensive overview of all ISO 13485 requirements.

Guidance for ISO 13485

Currently the TD Guide does have the task "Risk Class". This shall be extended by a question catalogue which guides you through the classification rules of MDR 2017/745 Annex VIII.

MDR Risk Class Guidance

To submit the entire Technical Documentation to the Notified Body, you can now download it as an entire report from BAYOOSOFT Themis. All information in the system as well as uploaded files are then compiled in the required folder structure for the Technical Documentation and made available as a "zip" file. 

Alternatively, for each task and thus each requirement, BAYOOSOFT THEMIS gives you the option of creating a single report. This is automatically marked and transferred to your documents without causing any loss of information. 

Generate your Documentation full zip or per single file

Currently the TD Guide does have the task "Risk Class". This shall be extended by a question catalogue which guides you through the classification rules of IVDR 2017/746 Annex VIII.

IVDR Risk Class Guide

BAYOOSOFT Themis provides a project based approach for performing documentation processes. In each project numerous to dos need to be managed, e.g. 

All those to dos need to be tracked from initiation/identification till publishing the changes. In order to easily manage those tasks a to do list and/or kanban board would be very helpful. With tasks directly tied to the documents (task items) they impact, users can improve task completion efficient, enhance project organization, and ensure seamless collaboration across teams. The result is increased productivity, reduced errors, and a more connected project management experience.

Integrated Project Management: Todo List / Kanban Overview

The new roles and rights concept takes user management to a new level. The "Team" page is now available for managing roles and rights. The assignment of rights is now much more fine-grained - this means your data is better protected. For a read-only access to projects (e.g. for the management level) the role "Observing Person" is provided. In addition, the new role "Approving Person" enables the release of tasks. 

fine granular rights management

Closely related to the creation of Technical Documentation is the processing of numerous documents, such as documents to be attached. These also require passing through approval processes and transparent tracking of the changes mage. Such functionalities are usually provided by document management systems (DMS), which enable an even wider range of functionality. This results in a high level complexity in these systems, which in turn complicates the processes.

We would like to discuss, to what extend functionalities of a DMS can be provided by BAYOOSOFT Themis in order to enable the most important DMS functions, but at the same time not to complicate the processing.

Allow users to manage and release documents (DMS lite)

During assessment of your documentation it is sometime helpful to allow auditors / the notified body to take a look into your current state of documentation on their own. Therefore, the fine granular user & rights management allows to assign user permissions with read only permissions.

Read Only Role for Notified Body

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? 

Users shall achieve transparency and get a comprehensive overview of all IVDR requirements related to Technical Documentation.

IVDR Documentation Guide - test it now

Users shall achieve transparency and get a comprehensive overview of all MDR requirements related to Technical Documentation.

MDR Documentation Guide - test it now

BAYOOSOFT THEMIS is a web-based software solution so that your employees can access the environment quickly and easily from all locations. You have a choice when it comes to deploying your organization-specific environment:

Hosting: Cloud or on-Premise use

When you assign a task to another person, comment on it or remove the person from the task, he or she will receive a notification, which can be viewed in the notification overview (top right of the view). If a team member is assigned to a specific task and a comment is created in that task, they will also receive a notification. 

In System Notifications

What changes have been made since I last viewed the task? Who added or removed a particular piece of information from the task? When was this information added? In the course of editing and review-processes, it is always useful to be able to track changes that have been made. To enable you to track adjustments to the technical documentation at any time when working in a team, the "Change History" area is now available for all tasks. 

Change History

Task-based work in the THEMIS DOCUMENTATION GUIDE enables you to process regulatory requirements in a structured manner. Each requirement of the technical documentation is mapped as a single task, which are logically linked to each other and thus ensure a single source of facts. In addition, each task has its own unique ID that cannot be changed manually, so that you can track all changes on a task-by-task basis and allocate them without error.

Task-based Approach

The working world is becoming increasingly volatile as regulatory requirements continue to increase. Issues such as collaboration, growing teams and working across locations are now commonplace in the world of medical device manufacturers. This is exactly why we are rethinking the way we approach technical documentation. The result is called BAYOOSOFT Themis - our web-based software solution for your technical documentation. Our vision? Your documents will be traceable, even if there are overlapping processes, redundant data and inconsistencies can be avoided. We enable teams to collaborate more effectively with each other and at the same time manage large amounts of data in a meaningful way. This is exactly why we focus on the teamwork, digitalization and compliance aspects of BAYOOSOFT Themis. 

Thanks to our many years of experience in creating technical documentation for medical devices, which we have gathered since 1998 with BAYOOSOFT Risk Manager, THEMIS DOCUMENTATION GUIDE is now available to you. It supports you in creating your technical documentation according to all the requirements of the Medical Device Regulation 2017/745 and prevents duplication of effort by centralizing your documents. Each document is represented as a task, and these tasks are interlinked, thus ensuring a single source of truth. After completion, you will receive the initial document for the Notified Body, which bundles all individual documents.

BAYOOSOFT THEMIS DOCUMENTATION GUIDE is the start of a new direction that will make the creation of technical documents easier and less complex. On this basis, BAYOOSOFT Themis will be expanded into a combination of editing work and document management system. The uploaded individual documents can be edited directly using the templates. Comprehensive processes, such as risk management, are first linked to the BAYOOSOFT Risk Manager and then lifted piece by piece to the Themis web platform. This gives you complete technical documentation - web-based and digital, with a focus on teamwork and compliance with current standards - and without the need to edit numerous Word and Excel files in parallel.

Welcome to the Future of Technical Documentation

BAYOOSOFT's expertise in the digitization of documentation processes began in 1998 and has continued to develop ever since. 

Besides continuous feature development and improvement the following milestones could be achieved:


Risk 1.0 is the predecessor to Qware® Riskmanager. It was the first and only software solution on the market that met the standard EN 1441 applicable in 1999. 


1999: Qware® Riskmanager was born as a new development according to EN ISO 14971:2000

Just two years later, the experience and insights from the first customer projects were used to develop a completely new version, which besides new technology and numerous functional extensions primarily covered the subsequent standard EN ISO 14971:2000. This version was the first to bear the name Qware® Riskmanager and was developed as a database-supported multi-user application. 


Qware® Riskmanager was continuously improved and expanded as software for risk management according to DIN EN ISO 14971. It incorporated changes to the standard as well as customer wishes, thereby serving as an optimal tool.
 Users appreciated the improved template management and automatic spellcheck feature. The implementation of the knowledge database enabled the use of data from already closed files. The consistently improved user interface in the software provided users with intuitive guidance, allowing new coworkers to quickly familiarize themselves with the tool. 


2011: Qware® Riskmanager gets a makeover

After 12 years of ongoing development, Qware® Riskmanager received a new user interface and now supported the database model under Microsoft SQL Server. Users valued the first extension module “Usability Management”, which was fully integrated into the risk management process. The new “Advanced Reporting” module enabled the free composition of printed editions.
Moreover, FMEA was offered as another method of risk analysis – to the delight of many customers.


The CSV import feature for the knowledge database enabled easy maintenance of existing data in Qware® Riskmanager, allowing new users to quickly get started with the software. Users now had the ability to perform risk analyses for products, components and processes with Qware® Riskmanager, thereby also opening up access for hospitals and clinics. 


2013: Dashboards & extension modules for Medical Electrical Equipment & Essential Requirements

The path towards complete technical documentation for medical devices gained further momentum from Version 5 with two additional extension modules. During this year, Qware® Riskmanager was expanded by the Medical Electrical Equipment module for preparing the conformity report according to 60601-1 as well as the Essential Requirements module according to IVDD 98/79/EC or MDD 93/42/EEC (2007/47/EC). Thanks to full integration into the risk management process, both modules enabled quick and reliable document creation as well as enormous time savings for users.
 Another feature that simplified the daily work of Qware® Riskmanager users were the dashboards for all modules. They displaced the current progress for projects and indicated potential inconsistencies and errors.


2014: Requirements Engineering - connecting requirements to Usability Engineering

The extension module Requirements Engineering allowed product requirements to be created and linked with Usability and Risk Management. The dashboard for the Requirements Engineering module showed users which requirements were currently outstanding without validation, verification and function coverage. It also offered an overview of functions and measures not assigned to any requirements at all.


The new basic functionalities Audit Trail, Digital Signature and Password Complexity enabled conformity with 21 CFR Part 11 in preparing risk management documents. When activating the Audit Trail, all changes carried out by users to data in Qware® Riskmanager were recorded. Digitally signed documents made it even easier for users to prepare technical documentation in compliance with FDA guidelines.


2015: Risk Management for Medical IT Networks

With the release of Version 8, users could conduct risk management for medical IT networks in accordance with EN 80001-1 in Qware® Riskmanager.


The Medical Device Ordinance was likewise added to the system. A medical device classifier supported the assessment of the risk class by answering simple questions. Major updates to comply with MDR 2017/745 and IVDR 2017/746 have been made.


sk Manager and is extended by Traceability and REST API

Not only does Qware® Riskmanager grow in its functional scope, BAYOONET AG also continuously expands its portfolio as a manufacturer. In addition to BAYOOMED and other business units, the software solutions Fileserver Management Suite and Qware® Riskmanager are now combined as BAYOOSOFT Access Manager and BAYOOSOFT Risk Manager under the BAYOOSOFT Management Software division.


2020: Clinical Evaluation & Machinery Directive

With version 10 of the BAYOOSOFT Risk Manager, the “Clinical Evaluation” module has been integrated into the software solution. The Risk Manager supports you in the process of the same name with intuitive user guidance and complete coverage of the process phases. The solution is compliant with both the MDR and the MEDDEV 2.7.1 rev4 and thus meets the current standards. 
A new extension module is now available to support the examination of the Essential Requirements for machinery according to Directive 2006/42/EC. Analogous to the functionality of the Essential Requirements module, a checklist filter allows the questions to be answered to be narrowed down. At the same time, answering the questions is fully integrated into risk management by linking, for example, hazards or measures. 


2021: Software life cycle process according to IEC 62304

With the extension modules Requirements Engineering and REST API in combination with Risk Management according to ISO 14971, BAYOOSOFT Risk Manager now offers an IEC 62304 compliant solution for the creation of technical documentation.


BAYOOSOFT Themis opens a new chapter in technical documentation. As the first available module, the Documentation Guide belongs to the next generation of systems for validated solutions around documentation processes of medical devices and in-vitro diagnostics. It offers all the basic functions of the Risk Manager, but can be installed as a desktop app or used in the web interface regardless of location and device. 

Previously in History

Discovering errors in your medical device during the production phase can result in extensive costs to rectify them. For this reason, it is recommended to perform an error analysis already in the early stages of developing your medical device. The method of failure mode and effect 
analysis (FMEA) enables you to identify any errors at an early stage and thereby avoid them during product development wherever possible.

Failure Mode and Effect Analysis (FMEA)

Besides PHA, FMEA or FMECA, which other Methodologies for Risk Analysis would be interesting?

What do you think? Leave us your feedback.

Shall we cover additional Risk Analysis Methodologies?

The medical device regulation MDR 2017/745 obliges you as a manufacturer of medical devices to perform a clinical evaluation throughout the entire lifecycle of the medical device. In addition to the systematic collection and analysis of pertinent clinical data from various sources, this encompasses a clinical follow-up of the medical device on the market.

BAYOOSOFT Themis shall enable you to perform a compliant clinical evaluation in a digital kind of way. 

They contain all relevant information for complying with the regulatory  requirements. At the same time, complete coverage of the process as well as intuitive user guidance enables you to identify and check relevant data straight away.

Clinical Evaluation acc. MDR

To minimize the risks of cyber attacks, data loss and other security threats, it is essential to establish and maintain an information security management system (ISMS). By conducting a structured survey of the IT status, determining the need for protection and implementing the appropriate security measures, the organization can be independently audited and certified.

Which policies are fulfilling which requirement of BSI Grundschutz? What is the current status of implementing those requirements? Who is currently working on it and what still needs to be considered in the QMS release?

Users shall achieve transparency and get a comprehensive overview of all BSI requirements related to ISMS.

Guidance for BSI-Grundschutz

The current focus of BAYOOSOFT Themis lies in standards & regulations related to Medical Devices and IT Security. But while generating your documentation often further regulations from other areas apply to your specific devices or environments. 

To ensure that your team covers those regulations as well it shall be possible to create own guidance modules and provide them in your individual environment as additional component of a project.

provide your team with your own guidance documents

If I do a change on this specification, how does it affect the other aspects of Technical Documentation? Which other information require adaptation?

We would like to discuss how we could support the process of Impact Analysis. What do you think? Drop us a feedback.

Impact Analysis

As a user I would like to make colleagues aware of specific tasks, even if they are not main responsible of it, e.g. if an attachment shall be added to a task. Also it would be great that the colleagues do not require to open Themis to be informed about assignments or notifications.

Mention and notify colleagues

Currently the Themis Documentation Guide covers requirements on the Technical Documentation according to MDR 2017/745 and IVDR 2017/746.

We want to discuss if requirements of other countries would be helpful within the Guide for Technical Documentation. 

What do you think? Which countries would be most helpful for you? Drop a feedback.

Shall we cover requirements of other countries in the Guide for Technical Documentation?

Besides the European Union and MDSAP there are other countries as well that define essential principles to Medical Devices and In-Vitro Diagnostics. Which other countries would be helpful for your devices?

Essential Principles for other countries

As soon as a new version of Management System has been released it must be published to all employees working according to the Management System. In case of Technical Documentation, it is additionally helpful to provide Notified Bodies with a read only view of the released documents of my Medical Device.

In both cases it would be helpful to publish all documents in a read only web view that can only be accessed by authorized users. Compared to PDF documents (current approach of providing documents) this would allow to directly an interactive navigation between linked documents as well as other filter and search functionalities.

Publish Documentation in Web View to other authorized users

Please note: It's a roadmap, not a promise. Items might be subject to change without notice.