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

The Medical Devices Regulation 2017/745 (MDR) regulates the classification of medical devices into groupings I, IIa, IIb and III. For in vitro diagnostic medical devices, on the other hand, the classification into risk classes A to D according to IVDR 2017/746 applies.

But which class do you ultimately have to assign your product to? BAYOOSOFT Risk Manager offers a simple and time-saving method. The software solution maps classifiers for medical devices as well as in vitro diagnostics.

Now new: The functions of the already established classifier for medical devices are also available with version 10.4 in conformity with the IVDR 2017/746 standard. This way, you can easily determine the assignment of the risk class by answering a few questions.

Features for marking and recognising inapplicable questions are also included.

2022-01 Blog Q1_Release RM 10.4_Grafik 1

Good to know

When answering individual questions, you will be supported by a compilation of the implementation regulations to be observed which can be displayed. In this way, you can reach the classification result of your IVD as quickly and conveniently as possible. After determining the classification result, you can have the corresponding report output in the documentation area.

In addition to the classification of in vitro diagnostics, BAYOOSOFT Risk Manager 10.4 contains numerous other features and enhancements – an overview.

Risk analysis
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.
CSV-Import
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.
Clinical evaluation
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.

According to the Medical Devices Regulation MDR 2017/745, the clinical evaluation is not only to be conducted centrally, but also over the entire life cycle of a medical device.

The extension module of the BAYOOSOFT Risk Manager enables you to generate the clinical evaluation in compliance with the MDR and MEDDEV 2.7.1 rev4. Learn more about the clinical evaluation in a product presentation.

Product presentation

Norms, standards and applicable documents
New report “Norms, standards and applicable documents” and extended overview of risk analysis
Document relevant and applied norms, standards and applicable documents in their entirety with BAYOOSOFT Risk Manager 10.4. With the new version, this information is detached from the previous version data report. This means that the information can be used more flexibly according to your requirements.
A new, extended overview report of the risk analysis is now also available. Here, the probability, the extent of damage and the risk before as well as after measures are presented in separate columns.
In addition, the information on individual measures decided, comments and the risk-benefit analysis are output.

Exclusively for customers: Everything at a glance

Are you already using the BAYOOSOFT Risk Manager as a customer? Then please ask us for the current change log document. All details on the new features and additions of version 10.4 as well as infographics of the individual innovations are clearly summarised here. Please feel free to contact us.

Get to know us

Would you like to get to know the BAYOOSOFT Risk Manager? Then take advantage of our 30-day free TRIAL or visit one of the upcoming online product presentations. You can find an overview of upcoming topics here.

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

Sounds interesting? Share our post

News