All in One Software Solutions and Expert Consulting for Managing Medical Device and Drug Combination Product Risks: Safety, Regulatory, Cybersecurity, and Quality
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
