Biomedical Device Engineering Risk Assessment

Project Name		Date
Device Description
Assessor(s)

Hazard	Possible Cause(s)	Potential Harm	Severity	Probability	Risk Level	Control Measures / Mitigations	Residual Risk
			Negligible Minor Moderate Serious Critical	Rare Unlikely Possible Likely Frequent
			Negligible Minor Moderate Serious Critical	Rare Unlikely Possible Likely Frequent
			Negligible Minor Moderate Serious Critical	Rare Unlikely Possible Likely Frequent

Overall Comments / Additional Information