{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fc8789c96-108d-45c2-8d48-576842965d68","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"EU MDR: Not All Doom and Gloom","description":"Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MDR)?\n\nIn this episode, Rebecca Sheridan shares some positive insights and updates regarding EU MDR and its In Vitro Diagnostic Regulation (IVDR). Rebecca is a former regulator herself, and now serves as Senior Director for Quality Assurance, Regulatory Affairs, and Clinical Affairs for the Advanced Wound Franchise of ConvaTec Limited.\n\nSome of the highlights of the show include:\n \n\u25cf\tEU MDR transition timeframe is very optimistic due to the complexity of today\u2019s medical devices.\n\u25cf\tThe infrastructure needed to navigate through the regulations is still in progress. So, minimal guidance is a major challenge for the medical device industry. \n\u25cf\tThe medical device industry is at a crisis point where collaboration must occur to be able to support patients, public health, and healthcare institutions.\n\u25cf\tAn extension would pose additional challenges. The legal process takes time, decreases available resources, and delays implementation of changes.\n\u25cf\tThe capacity of notified bodies is expected to increase by the end of this year. Many devices need to go through process that were previously unregulated. \n\u25cf\tDon\u2019t panic, stay calm. Engage early on with notified body and provide technical documentation and clinical data regarding design controls.\n\u25cf\tDuring the post-market phase, EU MDR/IVDR will impact companies\u2019 quality management system (QMS) and infrastructure due to required reporting.\n\nDownload our free EU MDR gap analysis tool here \u2192 https://www.greenlight.guru/mdr-gap-analysis-tool","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/9dcbc2af-e8c1-4d6c-a105-3e2ea4d77ee1/768f071d-16aa-45f4-9dde-adf92b7edfee.jpg"}