{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Ff2584503-bdea-421f-9917-e4abd2255a98","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Aligning True Quality and Compliance with MDDAP","description":"What does true quality mean? How does it relate to compliance? \n\nToday\u2019s guest on The Global Medical Device Podcast is George Zack of Two Harbors Consulting. \n\nGeorge shares his thoughts on these two tough questions and describes his involvement with the FDA\u2019s Case for Quality Program and CMMI Institute\u2019s Medical Device Discovery Appraisal Program (MDDAP). \n\nSome of the highlights of the show include:\n \n\u25cf\tMDIC oversees programs developed to assess organizations\u2019 beyond compliance of regulations to produce quality products. \n\u25cf\tCapability Maturity Model Integrated (CMMI): Third-party appraisal is performed against participating manufacturing organization to provide feedback.\n\u25cf\tBesides getting the appraisal and feedback, participating facilities are eligible for some regulatory modifications and benefits.\n\u25cf\tCompliance vs. Quality: Devices need to not only be compliant, but safe, effective, and readily available. \n\u25cf\tThere are similarities and differences between practices, assessments, appraisals, and audits. Don\u2019t prepare or study; be open and transparent.\n\u25cf\tUnderstand how the business operates to see the big picture. Practice areas include product integration, configuration management, and incident resolution.\n\u25cf\tFDA\u2019s Medical Device Single Audit Program (MDSAP) can involve more money, time, and people. MDDAP strives to be non-interruptive, streamlined, and faster.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/e756960a-dfea-4572-aa97-aba352c48437/5050a86a-db3e-4cd4-8253-545324ae8db2.jpg"}