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All-in-one Software Solution and Expert Consulting for Medical Device and Drug Combination Product Design Controls, Risk Management, Cybersecurity, and Safety Assurance Cases
Define organizational risk management policy - scales of severity, probability and risk acceptability matrix



Failure Modes and Effect Analysis (FMEA) - auotamatic integration with hazard analysis (legacy FMEA excel sheets can be converted)


Fault Tree Analysis Graphic Editor - automatic integration with hazard analysis and FMEAs


Hazard/Risk Traceability Matrix - product life cycle traceability


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