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Risk Assessment form FSA Reference: Medical Device Name: Manufacturer: SeverityProbability of harmValueLevelDescriptionValueLevelDescription5CatastrophicLoss of limb; life-threatening injury or death5Frequent
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How to fill out medical device risk assessment

How to fill out medical device risk assessment
01
Identify potential hazards associated with the medical device
02
Determine the likelihood of the hazard occurring and the severity of its potential harm
03
Evaluate the risk level based on the likelihood and severity
04
Implement risk control measures to mitigate or eliminate the identified risks
05
Document the risk assessment process and findings
Who needs medical device risk assessment?
01
Manufacturers of medical devices
02
Regulatory bodies responsible for medical device approval
03
Healthcare providers using medical devices
04
Patients and end-users of medical devices
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What is medical device risk assessment?
Medical device risk assessment is the process of evaluating and analyzing the potential risks associated with the use of a medical device.
Who is required to file medical device risk assessment?
Manufacturers, importers, and distributors of medical devices are required to file medical device risk assessment.
How to fill out medical device risk assessment?
To fill out a medical device risk assessment, one must gather relevant information about the device, identify potential risks, and document risk mitigation strategies.
What is the purpose of medical device risk assessment?
The purpose of medical device risk assessment is to ensure the safety and efficacy of the medical device for patients and users.
What information must be reported on medical device risk assessment?
Information such as device description, intended use, identification of hazards, risk evaluation, and risk control measures must be reported on medical device risk assessment.
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