Focus your energy on content instead of form
As the world’s leading software solution, the BAYOOSOFT Risk Manager enables you to create technical documentation for medical devices and in-vitro diagnostics easily and efficiently.
All information is captured in a clearly structured environment and the files are stored in an audit-proof manner and dynamically linked with each other in a fine-grained manner – making subsequent falsification or possible data loss a thing of the past. In addition, you avoid redundant data storage and can generate reports with the most current data at any time simply by pressing a button.
Your development and approval process is accelerated with BAYOOSOFT Risk Manager: Concentrate on the essential and increase productivity
The Risk Manager modules at a glance
Inform yourself in our lectures at Medica 2020
Monday, 16.11.2020
10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager
The regulatory requirements for the development and marketing of medical devices have increased continuously in recent years. The EU Medical Devices Regulation has given rise to numerous discussions. For the manufacturers of medical devices this means a continuously increasing documentation effort. As the world’s leading software solution, the BAYOOSOFT Risk Manager supports you in creating technical documentation for medical devices and in-vitro diagnostics.
Do you also want to speed up your way to approval? Get to know the Risk Manager better in our presentation. Don’t miss the opportunity to familiarize yourself risk-free and first-hand with the latest version of the validated approval accelerator.
11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill
Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data sets, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process in the face of more than 400 pages of requirements and more than 1,500 tests for applicability. Using the BAYOOSOFT Risk Manager, we will show you how you can accelerate this process systematically and interactively by up to 62%.
2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation
The process for the initial creation of technical documentation for a medical device is still relatively clear and structured. From purpose and risk classification, across requirements and risk files, all aspects are considered piece by piece.
But how do you proceed if the Technical Documentation needs to be revised due to market observation or other triggers? At which points do the changes have to be implemented and how do you later recognize the differences in different versions? We will show you how such changes to the technical documentation become child’s play thanks to the project- and version-based approach and the fine-grained dynamic data linking of the BAYOOSOFT Risk Manager.
3:30 P.M.: Risks in the Software Life Cycle IEC 62304 - tool-supported traceability
IEC 62304 defines a framework for MP software life cycles. Mostly traceability matrices are used to prove a compliant development – especially for large systems it becomes challenging. We will show you how the use of digital tools can support this process as well as a seamless integration into risk management and thus accelerate the approval process.
Tuesday, 17.11.2020
10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager
The regulatory requirements for the development and marketing of medical devices have increased continuously in recent years. The EU Medical Devices Regulation has given rise to numerous discussions. For the manufacturers of medical devices this means a continuously increasing documentation effort. As the world’s leading software solution, the BAYOOSOFT Risk Manager supports you in creating technical documentation for medical devices and in-vitro diagnostics.
Do you also want to speed up your way to approval? Get to know the Risk Manager better in our presentation. Don’t miss the opportunity to familiarize yourself risk-free and first-hand with the latest version of the validated approval accelerator.
11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill
Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data sets, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process in the face of more than 400 pages of requirements and more than 1,500 tests for applicability. Using the BAYOOSOFT Risk Manager, we will show you how you can accelerate this process systematically and interactively by up to 62%.
2:00 P.M.: Stop the Sisyphus work - Very easy adaptation and versioning of the technical documentation
The process for the initial creation of technical documentation for a medical device is still relatively clear and structured. From purpose and risk classification, across requirements and risk files, all aspects are considered piece by piece.
But how do you proceed if the Technical Documentation needs to be revised due to market observation or other triggers? At which points do the changes have to be implemented and how do you later recognize the differences in different versions? We will show you how such changes to the technical documentation become child’s play thanks to the project- and version-based approach and the fine-grained dynamic data linking of the BAYOOSOFT Risk Manager.
3:30 P.M.: Accelerate the clinical evaluation process with tool support
The use of digital tools can help medical device manufacturers to map the process of clinical evaluation according to the Medical Device Directive MDR 2017/745 at a central location, to standardize the procedure and to document it in a comprehensible way at any time, thus making this part of quality management faster and more efficient.
Wednesday, 18.11.2020
10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager
The regulatory requirements for the development and marketing of medical devices have increased continuously in recent years. The EU Medical Devices Regulation has given rise to numerous discussions. For the manufacturers of medical devices this means a continuously increasing documentation effort. As the world’s leading software solution, the BAYOOSOFT Risk Manager supports you in creating technical documentation for medical devices and in-vitro diagnostics.
Do you also want to speed up your way to approval? Get to know the Risk Manager better in our presentation. Don’t miss the opportunity to familiarize yourself risk-free and first-hand with the latest version of the validated approval accelerator.
11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill
Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data sets, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process in the face of more than 400 pages of requirements and more than 1,500 tests for applicability. Using the BAYOOSOFT Risk Manager, we will show you how you can accelerate this process systematically and interactively by up to 62%.
2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation
The process for the initial creation of technical documentation for a medical device is still relatively clear and structured. From purpose and risk classification, across requirements and risk files, all aspects are considered piece by piece.
But how do you proceed if the Technical Documentation needs to be revised due to market observation or other triggers? At which points do the changes have to be implemented and how do you later recognize the differences in different versions? We will show you how such changes to the technical documentation become child’s play thanks to the project- and version-based approach and the fine-grained dynamic data linking of the BAYOOSOFT Risk Manager.
3:30 P.M.: Risks in the software life cycle IEC 62304 - tool-supported traceability
IEC 62304 defines a framework for MP software life cycles. Mostly traceability matrices are used to prove a compliant development – especially for large systems it becomes challenging. We will show you how the use of digital tools can support this process as well as a seamless integration into risk management and thus accelerate the approval process.
Thursday, 19.11.2020
10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager
The regulatory requirements for the development and marketing of medical devices have increased continuously in recent years. The EU Medical Devices Regulation has given rise to numerous discussions. For the manufacturers of medical devices this means a continuously increasing documentation effort. As the world’s leading software solution, the BAYOOSOFT Risk Manager supports you in creating technical documentation for medical devices and in-vitro diagnostics.
Do you also want to speed up your way to approval? Get to know the Risk Manager better in our presentation. Don’t miss the opportunity to familiarize yourself risk-free and first-hand with the latest version of the validated approval accelerator.
11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill
Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data sets, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process in the face of more than 400 pages of requirements and more than 1,500 tests for applicability. Using the BAYOOSOFT Risk Manager, we will show you how you can accelerate this process systematically and interactively by up to 62%.
2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation
The process for the initial creation of technical documentation for a medical device is still relatively clear and structured. From purpose and risk classification, across requirements and risk files, all aspects are considered piece by piece.
But how do you proceed if the Technical Documentation needs to be revised due to market observation or other triggers? At which points do the changes have to be implemented and how do you later recognize the differences in different versions? We will show you how such changes to the technical documentation become child’s play thanks to the project- and version-based approach and the fine-grained dynamic data linking of the BAYOOSOFT Risk Manager.
3:30 P.M.: Accelerate the clinical evaluation process with tool support
The use of digital tools can help medical device manufacturers to map the process of clinical evaluation according to the Medical Device Directive MDR 2017/745 at a central location, to standardize the procedure and to document it in a comprehensible way at any time, thus making this part of quality management faster and more efficient.
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Contacts at BAYOOSOFT
Svenja Winkler
CEO
[email protected]
Franziska Weiß
Head of Sales
[email protected]