Risk Management

Risk management is a central part of all medical device development and drives your design.

Our built-in risk assessments permit risks, harms and risk control measures to be tightly integrated into the traceability.

This increases transparency, saves time, and highlights risk-dependencies between various parts of the system.

Automation of menial tasks and continuous checking for risk acceptance errors is applied wherever possible during the risk management work.

Perform Design Risk Assessments, Usability Risk Assessments, Manufacturing Process Risk Assessments in Aligned Elements. 

Combine Top-Down, Bottom-Up and hybrid approaches for the best possible risk identification coverage.

Use our predefined Hazard Category Lists and our importable questions from ISO 14971 Annexes, derive Use Errors from Use Scenarios, or generate Hazard Analysis items directly from Design Input and Design Output.

Assess potential hazards for applicability and let our automatic checks verify that all applicable risks have been correctly analysed.       

Apply our highly configurable Preliminary Hazard Analysis and FMEA components. Parameter naming, ranges, risk calculations, and thresholds are configured according to your needs.

Automatic checks ensure that all risks are mitigated and that all risk control measures are implemented and verified.

Connect the risk evaluations to your IEC 62304 Software Items, Software Units, and SOUPs to drive their Software Safety Classification.

Correct classification throughout the architecture is ensured by quality checks.

Each MS Words risk report type is completely customized to each customer's needs and uses the look-and-feel to fit each customers' Quality Management System, including layout, design, fonts, and colors.

The risk reports can include any upstream and downstream levels to depict the full story, from Risk Identification to the verification results of implemented Risk Control Measures.

The additional Risk Summary provides an overview of all Hazards before and after applying mitigations.

The report can be exported both to Word and Excel.