Module7 April 20264 min read
Module spotlight: Literature Review & Benefit-Risk Analysis
Strong clinical claims rest on evidence and honest weighing of risk. Literature review and benefit-risk analysis build that foundation.
By MoniDoseQMS Team
Before a device can claim a benefit, the evidence has to support it — and the risks have to be weighed honestly against it. Literature review gathers and appraises the published evidence; benefit-risk analysis turns it into a documented judgement.
What you can do
- Conduct and document systematic literature reviews
- Record benefit-risk analysis with clear reasoning
- Feed both into clinical evaluation and the risk file
- Keep the evidence base current as new literature appears
Why it matters
EU MDR requires that benefits demonstrably outweigh risks, supported by clinical evidence. A documented literature review and benefit-risk analysis are the backbone of that argument — and of the clinical evaluation that carries it.