{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F77ebd871-c470-4a7d-885b-f308fb50da68","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"Understanding FDA\u2019s Proposed Conformity Assessment Pilot Program\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/77ebd871-c470-4a7d-885b-f308fb50da68\"></iframe>","title":"Understanding FDA\u2019s Proposed Conformity Assessment Pilot Program","description":"Today on the Global Medical Device Podcast, we\u2019ll be talking to Mike Drues, who is a frequent guest on our show. He\u2019s the president of Vascular Sciences and a guru on all things related to regulatory compliance for medical device companies. \n\nWe\u2019ll be chatting about a new program that\u2019s just been announced. It\u2019s a pilot program on accrediting test organizations. The potential is that test compliance will be more consistent and that the process will be streamlined. \n\nSome of the highlights of the show include:\n\n\u25cf\tThe background of the Accreditation Scheme for Conformity Assessment (ASCA): When it came about, when it should be implemented, and what it\u2019s going to be used for.\n\u25cf\tHow current politics have impacted the development of this new program.\n\u25cf\tSome of the challenges that the ASCA will likely bring about.\n\u25cf\tThe importance of asking the right questions and running the right tests.\n\u25cf\tThoughts on what to do if a regulation or a particular type of test is not appropriate or not possible.\n\u25cf\tThe potential pitfalls of putting testing labs into a position where conflict of interest is a real concern.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/78a0e7f2-4c61-4ecd-9b09-72db8dac5787/8c366ca2-4b32-4b4e-be51-21f2501f5231.jpg"}