Risk management is a central part of all medical device development and has an extensive and fundamental impact on how you design your device.

Our tightly integrated ISO 14971 compliant risk assessments connect your design control items with risks, permitting risks, harms and risk control measures to affect and be affected by requirements, specification, verification and validation.

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

Risks appear in many shapes and forms, in different contexts and in different manifestation. Using a structured risk identification process is therefore paramount.

Aligned Elements supports the use of several risk identification methods and several different types of risk assessments, including:

• Top Down PHA Design Risk Assessments
• FMEA Risk Assessments
• Usability Risk Assessments
• Manufacturing Process Risk Assessments
• Cyber Security Risk Assessments

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.