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Rev. Latino Am. EnfermagemOriginal Article2010 Sept Oct;18(5):94351
www.eerp.usp.br/rlaeRisk Management in Techno vigilance: Construction and Validation of
a MedicalHospital Product Evaluation InstrumentCleuza
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How to fill out risk management in technovigilance
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Identify the potential risks in technovigilance
02
Assess the likelihood and impact of each identified risk
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Prioritize the risks based on their severity
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Implement the identified strategies and action plans
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Monitor and evaluate the effectiveness of the risk management measures
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What is risk management in technovigilance?
Risk management in technovigilance involves identifying, assessing, and prioritizing risks associated with medical devices or pharmaceutical products to ensure patient safety.
Who is required to file risk management in technovigilance?
Manufacturers, distributors, and healthcare professionals are required to file risk management reports in technovigilance.
How to fill out risk management in technovigilance?
Risk management in technovigilance should be filled out by documenting the identified risks, assessing their impact, and implementing strategies to mitigate those risks.
What is the purpose of risk management in technovigilance?
The purpose of risk management in technovigilance is to prevent and minimize adverse effects or events associated with medical devices or pharmaceutical products.
What information must be reported on risk management in technovigilance?
Information such as the nature of the risk, potential harm, likelihood of occurrence, and proposed risk mitigation measures must be reported on risk management in technovigilance.
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