{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fb9a3996c-3984-424c-be9f-75e6062b4709","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Risk Management from a Regulatory & Product Development Point of View","description":"Risk management for medical devices from a regulatory and product development perspective is the topic of today\u2019s podcast. \n\nWe 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). \n\nWe suggest following the ISO 14971 standard which provides manufacturers with a framework to manage the risks associated with the use of medical devices. \n\nAnother helpful guidance document is TR 24971 (Yea it\u2019s not free, but probably worth the couple hundred dollar investments). If your product will be released in Europe, then it\u2019s good to know the European version as well. \n\nFMEA is another popular risk management project tool and there are others available. \n\nWe then discuss the on-label use versus the off-label use of a product, and admittedly the whole thing is a dilemma. \n\nFrom a product liability perspective, if legal counsel can show a manufacturer knew a risk associated with a product that they did not mitigate, then the manufacturer can be held to a higher level of liability. \n\nWe dive deeper into the topic as we discuss:\n\nSetting a strategy regarding limiting discussion on use\nThe difference between intentional and unintentional off-label use\nThe meaning of unintentional misuse\nStaying focused on the intended use of the product\nWhen to push back with regulators \n \nRisk management can be overwhelming if you let it. Approach it from a process point of view and understand the documentation suggested. \n\ngreenlight.guru is about to make following risk management so much easier, featuring a module that allows you to conduct risk management activities and integrate with design control activities all in one, cloud-based solution. \n\nYour hosts today for the Global Medical Device Podcast, Jon Speer and Michael Drues Ph.D thank you for listening as they continue to share how you can implement their proven strategies at your organization.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/0956d657-c5df-43a7-8112-5d4d538e817c/33187a7c-a900-4145-affc-eee16ac5392e.jpg"}