Activity

  • dipanpatel replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 7 years, 4 months ago

    I agree with this post that labels should only be used as a last resort of precaution use. Product should go through immense testing and make sure there are no risk involved in using the product in its intended use. There should be a risk analysis on aspects of what would occur if the product was used incorrectly in various degrees. Obviously if the product is used incorrectly at a high degree, there is not much a company can do. However, by doing so may increase the margins of using the product and therefore mild miss use of a product does not lead to major harm. But in parallel with this, there should be proper training involved in using products that have a learning curve in using them. Having all this in place can be very effective and a label can be added to continue to ensure safe use.