1.3. Risk Management
Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk.
The Risk Management Plan establishes the project roadmap for the risk management activities to be conducted during the life cycle of the medical device. The Risk Management Plan must include the criteria for risk acceptability for the medical device being developed.
A preliminary assessment of the acceptable level of risk and benefit associated with the proposed device design. The product risk assessment is intended to outline the acceptable ratio of benefit and feature characteristics as compared to known and potential clinical adverse events.
The Hazard Analysis is a listing of all known and foreseeable hazards. Hazards must include use of the device in both normal and fault conditions. The list should represent a full description of the device and how it is intended to be used. Things to consider include previously recognized hazards associated with similar devices, and the foreseeable sequence(s) of events that may result in a hazardous situation.
A Harms List is a list of potential harms, the definition (including examples) of those harms and the associated severity level of those harms based on the Risk Acceptability Criteria definitions established for the device in the in the Risk Management Plan. This Harms List is important to assure that the descriptions of Harms used throughout the design documentation are constant in meaning (definition) and associated severity of harm with regards to the established Risk Acceptability Criteria in the Risk Management Plan.
Detailed assessments of the risks associated with the device design, risks to the patient and/or user when using the device and any manufacturing process risks for the device. Failure Modes and Effects Analysis (FMEAs) are part of risk analysis.
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Product Specification contains general information about the product, the required performance characteristics, material characteristics, packaging characteristics, the proposed product labeling and any installation/servicing requirements.
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A document that includes or refers to the location of the following information: Device specifications including software specifications, device installation specifications, device maintenance specifications, quality assurance procedures and specifications including acceptance criteria and any quality assurance equipment to be used, labeling specifications, including processes used, maintenance, and servicing procedures and methods.