Global Medical Device Podcast Powered By Greenlight.guru

Risk management for medical devices from a regulatory and product development perspective is the topic of today’s podcast. We take a look at a few tools to help in the process and liability as it relates to on-label vs off-label use (Some really interesting points on this topic). We suggest following the ISO 14971 standard which provides manufacturers with a framework to manage the risks associated with the use of medical devices. Another helpful guidance document is TR 24971 (Yea it’s not free, but probably worth the couple hundred dollar investments). If your product will be released in Europe, then it’s good to know the European version as well. FMEA is another popular risk management project tool and there are others available. We then discuss the on-label use versus the off-label use of a product, and admittedly the whole thing is a dilemma. From a product liability perspective, if legal counsel can show a manufacturer knew a risk associated with a product that they did not mitigate, then