Even though Risk Management and Usability Engineering are clearly two separate processes with unique requirements, they are interdependent and must communicate with each other during the entire product lifecycle. Risk Management identifies the risk of a medical device’s potential hazards and provides input to the design requirements. The process determines the likelihood and severity of those potential hazards, analyzing the device’s design, function and manufacture. Usability Engineering identifies and assesses risks associated with using the device. Controls used to develop product and usability specifications are established to mitigate the associated risks. The user interface, operation manual and/or instructions for use play key roles in Usability. Together, they help to ensure safe and effective medical devices are brought to the market. Their implementation takes time and effort, but is well worth the investment if field issues are mitigated.
Here are the first 2 points for successful integration of Risk Management and Usability during the lifecycle:
1. Define strong processes and illustrate the interactions between risk management and usability requirements. Each has its own set of international standardized requirements. Developing quality management system procedures that clearly define how to complete each requirement is essential. While procedures for risk management and usability stand alone, both the processes and the owners need to talk to each other. Ideally, the corresponding inputs and outputs of each process should map to the product development phases the company uses for design controls, including post-market surveillance.
2. Assign clear responsibilities for carrying out risk management and usability activities. The bottom line is that where ownership lies—Marketing, Engineering, Design Assurance, Regulatory, etc.—doesn’t matter, provided it is defined. Communicating roles and expectations is imperative to understanding exactly what is required, who will perform the tasks and when they are due. This concept is simple to grasp, but still many times there is confusion about who should own each process.
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