Tools & Templates

Medical Device Benefit Risk Assessments

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Risk Mitigation & Management
Compliance & Regulatory: MedTech
CRO Consulting

Benefit-risk assessments are important tools that help regulators determine whether or not the benefits of your device outweigh the risks. This resource provides insight into how the FDA performs a benefit-risk assessment and what factors you should consider in assessing the potential harms of your device.

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