{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F5a09cfaa-16db-4a5c-8952-a73438e37f33","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"How to Build a QMS for a Medical Device","description":"Where do you begin when building a quality management system (QMS) for a medical device? It\u2019s a task that is often delayed until later stages of development. Don\u2019t wait to implement a QMS; the consequences of waiting too long can lead to irreparable damage to your processes and, in some cases, product failures.\n\nIn this episode of the Global Medical Device Podcast, Jon Speer talks to quality and regulatory expert Mike Drues, president of Vascular Sciences. Together they discuss why a QMS is so important to a company as it sets up its business and processes. Laying a proper foundation for a QMS to operate at its full capacity is just as critical, which involves a shared mindset and philosophy across the organization that reinforces a culture of True Quality.\n\nSome highlights of this episode include:\n\u2022 A QMS is not a system of compliance. It should describe how business is conducted through policies, procedures, processes, and philosophies.\n\u2022 If a QMS consists of devices not manufactured by the company, it\u2019s an example of the copy-and-past approach to be compliant, but not customized.\n\u2022 A QMS is important to describe, document, and demonstrate roles, responsibilities, and rules to make decisions about products for patients.\n\u2022 A QMS focuses on four key areas: Accountability, traceability, consistency, and continuity.\n\u2022 Preamble/Introduction: One company\u2019s QMS should not be a carbon copy of another company\u2019s QMS. It should focus on its own mindset and philosophy.\n\u2022 Every QMS should include complaints, change management, and customer feedback to trigger notifications that affect safety, efficacy, and performance.\n\u2022 Product Lifecycle: During research and development, conduct post-market surveillance, beta test change management, and review risk management plan.\n\u2022 Document Management Control: All complaints and conflicts are not created equal. Get it right to make sure it\u2019s effective and efficient.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/460cf0a6-96ff-4f81-b30b-49de88354c7c/2400d2d2-a009-4c7c-92d8-41b7ceb8a0dc.jpg"}