The validated approval accelerator

The efficient route to technical documentation

The regulatory requirements on the development and distribution of medical devices have increased continuously over recent years. The EU Medical Devices Ordinance has been the subject of intense discussion. For the manufacturers of medical devices, this means more and more documentation work. After all, in case of doubt, unless it is documented, it probably wasn’t done. Manufacturers of medical products, in-vitro diagnostics or active, implantable medical devices therefore currently produce mountains of paperwork. And this trend is only increasing.

To break free from this tangle of red tape, the aim should be to break down monolithic documents into fine-grained data and have as many work steps as possible handled by specialized software solutions.

As the globally leading software solution, BAYOOSOFT Risk Manager supports you in preparing technical documentation for medical devices and in-vitro diagnostics. All relevant information is recorded in a clearly structured environment, stored in a central, audit-proof manner and dynamically connected with each other at a fine-grained level. This means you automatically avoid redundant data keeping. Reports are generated with the most up-to-date data at the press of a button.

BAYOOSOFT Risk Manager includes a dedicated administration area. Here you can import or create backups, define templates for risk graphs or FMEA catalogs as well as create or change descriptions of test procedures. There are many ways to add and maintain existing knowledge in the knowledge database, as well as manage master data and standard templates. Since every company has its own quality management handbook, type tests can be adjusted based on, for example, how a project, version, hazard or measure number is structured and the degrees of freedom with which users can act.

  • efficient

    Obtain approval for your medical device 62% faster

  • smart

    Self-learning system due to integrated AI

  • compliant

    Auditable technical documentation according to ISO 14971, IEC 62366, IEC 60601-1 and MDR 2017/745

  • ready to use

    Get started straight away with the preconfigured standard processes

  • certified

    awarded with the DigiLab certificate

“…the processing time for our technical documentation has at least halved thanks to BAYOOSOFT Risk Manager.”

More than 3,000 product files have been generated for medical devices using BAYOOSOFT Risk Manager since 1998. Our customers report up to a 62% increase in process speed. Thanks to clear structures and dynamic linking, the focus is on what’s important – the content.

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efficient

               obtain approval for your medical device 62% faster

As a manufacturer, you can only put medical devices into circulation or operation if your products bear the CE marking. In the case of medical devices, this stands for safety, performance and effectiveness. Product-specific legal requirements need to be observed in order to affix a CE marking. To meet these requirements, your medical devices undergo a complex process for market approval and the necessary documentation (of both technical and medical aspects) is extensive.

BAYOOSOFT Risk Manager helps you to safely achieve market placement – with a view to the safety of patients and users. With the market-leading software solution, you have an auditable tool for accelerating the process of market approval by:

The medical device classifier according to MDR 2017/745 provides you with an initial reference for classifying your medical device. This only needs to be supplemented with a justification in consideration of the intended purpose and associated risks.

At the same time, the efficiency calculator available in the software solution offers you a valuable function for checking the risk of your medical device. It automatically calculates the efficiency of the risk-reducing measures taken by the user and summarizes them in a clear list of results. This way, you can see at a glance which measures would reduce multiple risks at once and which measures reduce risks that lie outside the acceptable range, for example.

self-explanatory

easy to understand thanks to the intuitive user guidance

As a user of BAYOOSOFT Risk Manager, you experience intuitive user guidance that allows you to carry out the sophisticated risk management process for your medical devices. The user guidance is based on the process-oriented approach of risk management according to ISO 14971 – from risk analysis and risk assessment through to post-market surveillance. This structured approach enables you and your coworkers to work more intensely and successfully with the solution, while also reducing induction and training outlay at the same time. The knowledge platform set-up and structured template management simplify efficient, cross-project work. The help feature and functional icons make it easy for new coworkers to get started with the application.

smart

self-learning system due to integrated AI

BAYOOSOFT Risk Manager is a validated, market-leading software solution that helps you detect risks in the development process at an early stage and visualize the risk distributions. After starting the program, the existing technical documentation is analyzed fully automatically and checked for inconsistencies. You then receive a clear summary of the result in the dashboard. This way, you can instantly see where documentation steps are not yet completed or where there are inconsistencies. This helps to prevent errors, since relevant data is automatically checked after each step and summarized in the dashboard.

At the same time, BAYOOSOFT Risk Manager learns from all previous documentation using AI and recognizes while you enter text whether other hazards or causes were identified with other similar products in the past, for example, or whether measures were implemented which you have not yet considered with the current product. The program therefore provides valuable assistance for implementation.

The knowledge database also leads to synergy effects across different projects and supports you in utilizing know-how throughout the entire company. Smart suggestions are automatically presented at appropriate points.

compliant

               auditable technical documentation according to ISO 14971, IEC 62366, IEC 60601-1 and MDR 2017/745

The validated approval accelerator helps you generate compliant technical documentation for your medical devices in accordance with ISO 14971, IEC 62366, IEC 60601-1 and MDR 2017/745. Here, BAYOOSOFT Risk Manager guides you through the standard requirements in a structured way, also using illustrative examples provided.

You can submit the reports generated in BAYOOSOFT Risk Manager to designated bodies in Europe as well as the FDA. The requirement of FDA 21 CFR Part 11 is fulfilled with the settings of the three parameters: audit trail, password policy and digital signature. What’s more, all data is auditable and stored up-to-date in a central database. You can track all changes using the audit trail.

BAYOOSOFT Risk Manager is also validated according to DIN EN ISO 13485:2017. Based on the GAMP 5 guidelines for computerized validation, the market-leading software solution has undergone the validation process as category-four software and successfully passed all aspects – from the requirements and configuration specifications through to the acceptance test.

ready to use

get started straight away with the preconfigured standard processes

The software solution is based on a project and version-oriented approach that allows you to prepare system risk analyses and product risk analyses. In the application, you create projects for each lifecycle phase of the medical device. All relevant information is recorded in a clearly structured environment, stored in a central, audit-proof manner and dynamically connected with each other at a fine-grained level.

For preparing the documentation, the structure of BAYOOSOFT Risk Manager is based on the process-oriented approach of risk management for medical devices according to ISO 14971. The preconfigured standard processes are representative and correspond to the approach for ensuring that the risks of your medical devices are known, controlled and acceptable in a benefit comparison.

With the extension modules, the modular structure of the validated approval accelerator also enables you to prepare compliant usability engineering files according to IEC 62366, the conformity report according to ISO 60601-1 and fulfill the essential requirements according to MDR 2017/745 and IVDR 2017/746. The processes of these standards are fully integrated into the risk management process in accordance with ISO 14971 and lead you step by step to your final report, following the tried and tested macrostructure.

market proven

                more then 3,000 product files generated since 1998

BAYOOSOFT Risk Manager (formerly Qware® Riskmanager) has established itself on the medical devices market since 1998 as a reliable software solution for conveniently generating compliant technical documentation for medical devices. The validated approval accelerator is recognized worldwide – both among customers from the medical and pharmaceutical sector as well as designated bodies. Accelerate your market approval with the clear and tested approach and create positive effects on costs and time expenditure. Get to know BAYOOSOFT Risk Manager today.

certified

awarded with the DigiLab certificate

As a software solution with high quality standards and efficient regulatory affairs processes, BAYOOSOFT Risk Manager has received the DigiLab certificate. Our solution meets all criteria for conformity with normative requirements, usability, flexibility for adaptation to individual processes of medical device and IVD manufacturers, authorisation concept, willingness and ability to cooperate and cybersecurity.

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Modularity for a needs-based solution

BAYOOSOFT Risk Manager features a modular structure, making the software solution self-explanatory and ready to use straight away. Your users therefore only find the features in the system which they actually need for their daily risk management work. The following modules and packages are available:

Basic Module – Risk Management – ISO 14971

Usability Engineering – IEC EN 62366

Essential Requirements – MDR 2017/745 und IVDR 2017/746

Medical Electronic Equipment – IEC 60601-1

Medical IT-Networks – IEC 80001

Requirements Engineering

Clinical Evaluation

Software-Lifecycle-Process

REST API

Advanced Reporting

Pre-Validation Package

Discover BAYOOSOFT Risk Manager.

Arrange a consultation for an individual product presentation today. Our risk management experts will be happy to present you BAYOOSOFT Risk Manager in detail:

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