{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Ff87855f6-992b-460d-8189-f988a6faec00","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"FDA is Expanding its Case for Quality Program... Should Your Company Participate?","description":"Depending on the level of quality and compliance, medical devices can impact patients\u2019 lives for better or for worse. Fortunately, FDA recently announced plans to open up and expand participation for its Case for Quality Initiative. \n\nToday\u2019s guest is Mike Drues of Vascular Sciences. We discuss the benefits and incentives for compliant and noncompliant companies to participate in the Case for Quality program. Compliance doesn\u2019t necessarily ensure quality. \n\nSome of the highlights of the show include:\n\n\u25cf\tPilot Program Premise: Partnership between FDA, MDIC, and CMMI Institute to promote compliance and focus on true quality products and processes.\n\u25cf\tCase for Quality is newer program with somewhat skewed participation from larger companies due to incentives favoring PMA Class III products. \n\u25cf\tCase for Quality: Advantages for participating include being excused from routine FDA inspections when state of compliance was demonstrated previously.\n\u25cf\tMaking changes to positively impact PMA products involves challenging process to submit a supplement. Are regulatory requirements for changes necessary? \n\u25cf\tMicromanage Case for Quality: Root cause for such regulations is to prevent shortcuts and oversee those that don\u2019t know what or how to be in compliance.\n\u25cf\tWhy are some companies not in compliance? They should participate in the Case for Quality Initiative to learn what they need to do.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/d094da24-1971-4e56-b457-c84e6c91cd91/315064c9-d425-49cc-9344-3721db162bf8.jpg"}