A hazard is a potential source of harm. A hazardous situation is the circumstance where people, property, or the environment are exposed to that hazard. The harm is the injury or damage that can result.
Write risk entries in clinically meaningful language. “Software issue” is too broad; “incorrect dose recommendation shown to clinician” is easier to evaluate and control.
Include normal use, foreseeable misuse, maintenance, cleaning, cybersecurity where relevant, use environment, accessories, and patient or user characteristics.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.