In order to keep efforts and costs as low as possible despite increasing requirements from laws, guidelines and standards for manufacturers of Medical Devices and In Vitro Diagnostics, BAYOOSOFT provides with the Risk Manager a validated and compliant solution to increase your regulatory productivity. It digitizes the processes for creating Technical Documentation and accelerates the impact assessment of changes by centrally managing and connecting discrete information units. Not only individual tasks, but entire processes are therefore optimized, resulting in a far lower investment of resources and reduced error quotas than would be the case with manual processing. This allows you to sustainably reduce operational efforts, e.g. when updating existing files, while at the same time increasing the acceptance of the developed files by notified bodies.
The efficient and standard-compliant approach is completed by a self-learning knowledge database, with which the generated knowledge steadily grows in a cross-project manner. The information is made available company-wide to your authorized employees and often repeated elements are provided for the generation of new documentation.
Thanks to the multi-user capability, colleagues can enter content and results in parallel in the same document and are guided through the process in a structured way by following the process from top to bottom in the menu. This leads to an intuitive user interface that is easy to use.
The risk-based approach enables intensive and successful work with the solution and at the same time reduces introduction and training efforts.
In a clearly structured environment, all relevant information is captured and dynamically linked in a fine-grained manner. Redundant data does not exist. The knowledge database also leads to synergy effects across projects and supports the use of the acquired know-how throughout the company.
The creation of a knowledge platform and a structured template management allow for an efficient and at the same time secure implementation of the demanding documentation processes.
BAYOOSOFT Risk Manager offers a project- and version-based approach for processing your Technical Documentation. Depending on the life cycle phase, changes made may be historically recorded in versions. Reports are generated automatically with the selected version status with just one click. The audit-proof, fine-grained authorization system ensures that only authorized persons have access. The integrated audit trail enables changes to be traced at any time.
Extensive functionalities and services
A risk-based process approach using PHA and FMEA is key to fulfil normative requirements.
Trace product requirements to identified risks and tests for verification and demonstrate compliance with regulations such as MDR, IVDR, IEC 60601-1 or 2006/42/EC.
Embrace the digitalization of validation processes such as Clinical Evaluation or Usability Engineering.
These are the main benefits provided by BAYOOSOFT Risk Manager.
Get to know the approach for an efficient and compliant Technical Documentation.
To start your documentary activities even faster, the Pre-Validation Package is a valuable companion during your software validation process.
Due to the modular structure of BAYOOSOFT Risk Manager, we enable you to adapt the scope of functions to the use in your company according to your needs – without reinstalling the software. The range of additional modules is continuously being expanded. For the use in international environments the Risk Manager was designed multilingual.
The key features of BAYOOSOFT Risk Manager form the basis for standard-compliant Technical Documentation and run like a thread through the entire software. From classification according to MDR & IVDR to fine granular authorization management: For almost every SOP requirement you will find suitable functions to increase your productivity.
According to DIN EN ISO 13485:2016, all systems involved in the process must be validated. In accordance with these requirements, the BAYOOSOFT Risk Manager has undergone a validation process in accordance with GAMP 5 – Guidelines for Computer-Assisted Validation and is validated as Category 4 software.
We are pleased to support you with software validation according to ISO 13485 in your environment – for example with the following service options
“Especially for manufacturers of Medical Electrical Equipment, BAYOOSOFT Risk Manager is the first choice in my point of view. I can only recommend it to everyone!”
“BAYOOSOFT Risk Manager allowed us to bypass the time-consuming manual work. The software guides us through the process without errors, you can’t deviate, you can’t forget anything and you get a flawless result.”
“I can recommend BAYOOSOFT Risk Manager to anyone who needs to create a comprehensive risk management file.”
BAYOOSOFT – The Business Unit for Management Software of BAYOONET AG
Focus on the essentials and thus increase productivity
This is made possible by the in-house software products of BAYOOSOFT, which has been very successfully creating turnkey software solutions since 2001. Designed as management software, the solutions focus on highly regulated areas and critical infrastructures. Based on our many years of experience, we know in detail the special needs and requirements of making IT processes more flexible and optimising them. For companies, this enables us to create value that gives them a lasting competitive advantage, and we are proud of the fact that our customers continually attest to this.
The BAYOOSOFT team enthusiastically develops and markets a comprehensive product portfolio. Our quality management processes, certified by TÜV Hessen to ISO 9001, are an expression of our passion for sustainable business solutions and strong customer focus.
The highly qualified team works on-site at the headquarters in Darmstadt as well as at the locations in Munich, Berlin and Cologne. We do not outsource any work to other companies, such as in the IT nearshore or offshoring sector. All of our co-thinkers are personally contactable and your personal solution engineer can also support you directly on site if desired and required.
Find out about all the latest developments relating to the BAYOOSOFT Risk Manager as well as specialist articles on processes and regulations relating to the manufacture of medical devices and in vitro diagnostics. Browse directly through our latest articles or visit our full blog.
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Julia Pfeffinger2022-08-10 16:56:532022-08-17 16:57:08Agile IEC 62304: How you can use the standard in the development process
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Julia Pfeffinger2022-07-22 13:26:322022-07-22 13:26:32Release: BAYOOSOFT Risk Manager Version 10.5
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Julia Pfeffinger2022-07-20 18:22:072022-07-20 18:22:07General safety and performance requirements: What applies to medical devices under MDR and IVDR? 
Svenja Winkler
COO/Director Management Solutions
[email protected]
Franziska Weiß
Head of Sales [email protected]
