In today's competitive business scenario, the search for excellence in quality is fundamental to the success and reputation of any organization. With Vesta Academy's ISO 14971:2020 training, you will be fully prepared to stand out as a professional capable of driving quality and efficiency in your company.
The trained professional must be able to identify and evaluate the risks associated with a medical device. This includes evaluating potential hazards, estimating the risk associated with those hazards, and evaluating how acceptable those risks are.
Once the risks have been identified and assessed, the professional must be able to take measures to control these risks. This may include modifying the design of the device, implementing security controls, or adding appropriate warnings and instructions for use of the device.
After implementing risk controls, the professional must be able to monitor the effectiveness of these controls and make adjustments as necessary.
The professional must also be able to adequately document all steps of the risk management process in order to demonstrate compliance with applicable regulations and standards.
