Integrated risk assessments
Risk management is a central part of all medical device development. Aligned Element's built-in risk assessments permit risks and measures to be tightly integrated into the trace landscape. This increases transparency, saves time and highlights risk-dependencies between various parts of the system.
In accordance with the Aligned philosophy, automation of menial tasks and continuous checking for errors is applied wherever possible during the risk assessment work.
Preliminary Hazard Analysis
Aligned Elements provides a Preliminary Hazard Analysis to get a grasp of potential system harms. The generated measures are automatically grouped acccording to their effectiveness. Potential Hazards from e.g. 60601-1 commplete the picture and provide full control over the system risk management.
The PHA Risk Analysis in Aligned Elements can be connected to your IEC 62304 architecture including Software Items, Software Units and SOUPs to drive the safety classification of these items with automatic checks ensuring correct classification according to IEC 62304.
Failuremode and Effect Analysis
Aligned Elemens provides an integrated FMEA component. The parameter naming, levels, risk probability calculation (RPN) and risk thresholds can be configured according to your needs. Automatic checks ensure that all defined mitigations are implemented.
The FMEA component minimizes errors by automatically combining effects and causes and calculating the RPN before and after mitigations.
All risk assessments can be exported into MS Word and synchronized at will. The risk report look-and-feel is customizable to fit each customers' Quality Management System.
The additional risk summary report provides an overview of all Hazards before and after applying mitigations. The report can be exported both to Word and Excel.