The validated approval accelerator
obtain approval for your medical device 62% faster
As a manufacturer, you can only put medical devices into circulation or operation if your products bear the CE marking. In the case of medical devices, this stands for safety, performance and effectiveness. Product-specific legal requirements need to be observed in order to affix a CE marking. To meet these requirements, your medical devices undergo a complex process for market approval and the necessary documentation (of both technical and medical aspects) is extensive.
BAYOOSOFT Risk Manager helps you to safely achieve market placement – with a view to the safety of patients and users. With the market-leading software solution, you have an auditable tool for accelerating the process of market approval by:
- Meeting the essential requirements and performing the conformity assessment procedure
- Applying the integrated, process-oriented approach of risk management
- Generating standardized reports
- Avoiding redundant data through the use of the knowledge database and template management
The medical device classifier according to MDR 2017/745 provides you with an initial reference for classifying your medical device. This only needs to be supplemented with a justification in consideration of the intended purpose and associated risks.
At the same time, the efficiency calculator available in the software solution offers you a valuable function for checking the risk of your medical device. It automatically calculates the efficiency of the risk-reducing measures taken by the user and summarizes them in a clear list of results. This way, you can see at a glance which measures would reduce multiple risks at once and which measures reduce risks that lie outside the acceptable range, for example.
self-learning system due to integrated AI
auditable technical documentation according to ISO 14971, IEC 62366, IEC 60601-1 and MDR 2017/745
ready to use
get started straight away with the preconfigured standard processes
The software solution is based on a project and version-oriented approach that allows you to prepare system risk analyses and product risk analyses. In the application, you create projects for each lifecycle phase of the medical device. All relevant information is recorded in a clearly structured environment, stored in a central, audit-proof manner and dynamically connected with each other at a fine-grained level.
For preparing the documentation, the structure of BAYOOSOFT Risk Manager is based on the process-oriented approach of risk management for medical devices according to ISO 14971. The preconfigured standard processes are representative and correspond to the approach for ensuring that the risks of your medical devices are known, controlled and acceptable in a benefit comparison.
With the extension modules, the modular structure of the validated approval accelerator also enables you to prepare compliant usability engineering files according to IEC 62366, the conformity report according to ISO 60601-1 and fulfill the essential requirements according to MDR 2017/745 and IVDR 2017/746. The processes of these standards are fully integrated into the risk management process in accordance with ISO 14971 and lead you step by step to your final report, following the tried and tested macrostructure.https://www.riskmanager.net/module-funktionen/module/#essential-requirements-mdr-ivdr