ID: Lorem ipsum dolor sit amet, consectetur adipiscing elit.
The risk assessment is performed according to the Risk Management Plan for Ut enim ad minim veniam. The risk analysis is performed according to ISO 14971:2019 to satisfy the requirements and is based in part on ISO/TR 24971:2020.
The software safety classification according to IEC 62304:2006 is:
Class B: Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.
The risk assessment takes into account the intended use of Ut enim ad minim veniam and its reasonably foreseeable misuse, characteristics of the device related to safety, hazards and hazardous situations associated with use of the device, and estimation of risk based on the hazardous situation. The process of identifying hazards, hazardous situations, and harms as well as probabilities associated with each shall follow the steps identified in the Risk Management Plan.
The risks will be analyzed according to ISO 14971 and the risk matrix created in the Risk Management Plan. The risk control measures will be implemented and undergo verification according to the Risk Management Plan and the SOP Integrated Software Development software lifecycle stages. The residual risk for each individual risk will be analyzed and overall residual risk will be determined as to whether it is acceptable or not.
Risk types can include but are not limited to risks related to:
P = Probability of Occurrence, S = Severity, P1 = probability of hazardous situation occurring from hazard, P2 = probability of harm occurring from hazardous situation. p1*p2 = Overall probability of harm occurring
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Risk controls methods are verified according to Risk Management Plan for Ut enim ad minim veniam. This risk analysis can be updated following verification procedures to determine effectiveness of risk control measures and update new risks identified during the product development process according to SOP Design Controls.
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The potential risks, hazards, hazardous situations, and harms have been identified and mitigated according to ISO 14971:2019 and ISO/TR 24971:2020. Risk control methods have been established and verified throughout the product development process.
The overall residual risk has been evaluated and determined to be acceptable for Ut enim ad minim veniam. As such, the risk profile for the device is considered acceptable.
