Classification of in vitro diagnostics (IVDR) and many more features – the BAYOOSOFT Risk Manager 10.4

Documentation of the source of risk and labelling of measures that do not cause risk

Within the framework of the risk analysis, you can now assign a source to each hazard in the analysis tree. For this purpose, a corresponding selection field is available at each hazard. The selection options are based on the sources maintained within the knowledge database.

In addition, you can explicitly mark measures that cause hazards and document them as such. In accordance with the requirements of ISO 14971, it is now also possible for you to note that a measure does not cause a hazard.

Supplied documents

The applicable documents managed as part of the risk management plan can now be quickly and conveniently imported into the list of applicable documents on a larger scale via an import in the form of a CSV file as an alternative to entering them on the user interface.

Table layout according to MDCG guidance and work organisation for search evaluation

The Clinical Evaluation module enables efficient documentation of the scientific evidence for equivalence as required for claiming the so-called equivalence route. With the new version, the table layout according to MDCG is available in the associated report “Proof of equivalence for the device being assessed”.

In addition, as part of the identification and evaluation of clinical data, you can collect all imported data sets centrally and evaluate them individually in a multi-stage process and check their relevance for the clinical evaluation in the course of this.

You can now name a responsible team member or an external employee for each search result. It is also possible to filter the search results according to the defined responsibility.