{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F36245385-92c8-42f4-829e-62e0b14c0ead","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"7 Habits of Highly Effective True Quality Medical Device Professionals","description":"What is true quality? How do you achieve it? \n\nIn this episode, Jon Speer of Greenlight Guru and Mike Drues of Vascular Sciences discuss habits of highly effective, true quality medical professionals. \n\nTrue quality does not simply refer to being compliant with regulations - but going above and beyond. It\u2019s your responsibility to improve the quality of life. \n \nSome of the highlights of the show include:\n \n\u25cf\tHabit 1: Quality management system (QMS) should be simple and right sized; customize it to describe your business\u2019 processes. \n\u25cf\tHabit 2: Move away from paper-based approaches - may make your QMS fragile and not scale; digitize documentation with a purpose-based solution.\n\u25cf\tHabit 3: Always be audit ready; if the FDA is coming, you shouldn\u2019t behave differently or hide something. Be transparent, and let FDA show up anytime.\n\u25cf\tHabit 4: Implement risk-based approaches and decision making; understand the scope, magnitude, and potential impact of issues and complaints.\n\u25cf\tHabit 5: Be proactive rather than reactive to events; don\u2019t wait for something to happen to do something about it. Monitor, evaluate, track, trend, and take action.\n\u25cf\tHabit 6: Break down silos/barriers by understanding the purpose and benefits of regulations and regulatory agencies. \n\u25cf\tHabit 7: Shift from compliance-minded to true quality focus; you develop, design, and test a product to make sure it\u2019s safe and effective, but the ultimate power is knowing that it\u2019s for real physicians and patients. \n \nLinks:\n \nMike Drues\nGreenlight Guru\n510(k)\nThe 7 Habits of Highly Effective People by Stephen Covey\n \nQuotes:\n \n\u201cWe\u2019re all in this to improve the quality of life. We all have a quality role that we play into this process.\u201d - Jon Speer \n\n\u201cSometimes, convincing companies to go above and beyond is what is required. It\u2019s not always an easy thing to do.\u201d - Mike Drues\n\n\u201cSometimes, people look at a quality system as a burden. I want you to look at it as something you get to do that describes your business\u2019 processes.\u201d - Jon Speer\n\n\u201cIf you\u2019re doing all the things that you should be doing anyway, then you have absolutely nothing to worry about.\u201d - Mike Drues","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/e583b8e2-1b49-4ed9-be20-84a1aa476dcf/4a2ae8c5-f98b-49b5-9cae-3b772f2d07ce.jpg"}