{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F5d33fc84-d064-4b09-b122-13f5610dc4ed","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Implementing Changes to SaMD under New EU MDR","description":"Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the new European Medical Device Regulation (EU MDR) continue to create angst and uncertainty.\n\nIn this episode, Andrew Wu and I discuss the ramifications of these changes. Andrew is a software consultant with Rook Quality Systems and software as a medical device (SaMD) expert.\n\nSome of the highlights of the show include:\n\n\u25cf\tMost noticeable change is a broader definition of what qualifies as a medical device to include prediction and prognosis of diseased state.\n\u25cf\tSaMD classification changes are drastic but vague following MDR implementation.\n\u25cf\tGap analysis should be performed to identify changes that companies need to make to conform with changes.\n\u25cf\tGroups that will most likely experience the greatest impact due to classification and qualification changes:\n\u25cb\tProducts on market in EU as Class I software will be uplisted as Class IIa.\n\u25cb\tProducts that provide clinical information for informed clinical decisions.\n\u25cf\tTimeline and Some Next Steps: Demonstrate conformance, update quality management system (QMS), notify regulatory body to MDR by May 25, 2020.\n\u25cf\tPlan, prioritize, and understand your regulatory conformance strategy going forward. \n\u25cf\tCompare and Contrast EU MDR and US FDA: Developing regulatory framework in different directions, but share consensus on sensitive nature and usage.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/6aaf2e76-7105-4f82-bab7-ad96dc3c902c/8f3f5520-6953-4002-bb52-da90f7a3fb8a.jpg"}