BAYOOSOFT Risk Manager
The efficient route to technical documentation
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RISK MANAGEMENT ACCORDING TO DIN EN ISO 14971
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 are fully integrated in BAYOOSOFT Risk Manager for preparing compliant risk management documents. The procedure follows a clearly structured approach based on the process steps of the standard:
Here, BAYOOSOFT Risk Manager offers the choice between two risk analysis methods:
In both cases, you can define global risk templates and set your own individual risk definitions in each project, and even in each version.
Essential Requirements According to MDR 2017/745 & IVDR 2017/746
Conformity Report for Medical Electrical Equipment
Software Lifecycle Process
Requirements of IEC 62304 on software lifecycle processes
BAYOOSOFT Risk Manager offers a solution for preparing technical documentation in compliance with IEC 62304 for developing your medical device software. Here, the two extension modules Requirements Engineering and REST API are combined with risk management according to ISO 14971:
Seamless integration of requirements management into risk management enables you to replace redundant entries and manual copying with just a few clicks in the system. Connect requirements with functions in risk management as well as requirements at a further level (traceability) or quickly and easily create new requirements based on the effective measures.
Create test plans for validating and verifying the requirements and document the respective test runs. Test cases are linked directly with requirements, also allowing you to ensure permanent traceability here.
Ensure all requirements are linked with user stories in source code management, for example. The REST API opens up the further system environment for you in this connection. Integrate your source code management or ticket system for post-market surveillance – also enabling you to directly link with elements at other levels.
Finally, simply generate your traceability matrices at the press of a button based on the auditable and centrally stored, fine-grained and dynamically interconnected information. Moreover, the integrated version management of BAYOOSOFT Risk Manager enables you to “close” certain version statuses, so that they can no longer be changed retroactively.
Which systems should you link for IEC 62304-compliant software development?