ISO 14971 Medical Device Risk Management & Assurance Case

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

Fault Tree Analysis Example

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

Fault Tree Analysis Example

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

Fault Tree Analysis Example

Hazard/Risk Traceability Matrix - product life cycle traceability

Fault Tree Analysis Example