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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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