{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fb2c25b48-7de6-43c7-b989-9f8db619fc9c","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Tips for Success When It Comes to IEC 60601 with Leo Eisner","description":"IEC 60601 is a challenge for companies that are developing electronic medical devices. It\u2019s wise to have a guide to help you understand and work through the process, and today we have a guest who will give you the guidance you need.\n\nLeo Eisner, founder and principal consultant of Eisner Safety Consultants, knows IEC 60601 inside and out. \n\nLeo has a great background in compliance, quality systems, and more. For nearly two decades, he has been heavily involved in the standards committees and has been working as a consultant. \n\nEisner Safety Consultants helps clients get through the product safety and regulatory processes. Today he shares some great insights on the 60601 approval process.\n\nSome of the topics we\u2019ll discuss today include:\n\n\u25cf\tWhat makes the 60601 process different from the other regulatory compliance processes.\n\u25cf\tSome of the details on the differences between creating a device for the ER vs. for home use and for use in other types of facilities.\n\u25cf\tTips on preparing for success when creating a timeline for getting through the 60601 process, as well as some of the steps involved.\n\u25cf\tDifferences between different types of safety labs and the criteria that\u2019s vital to understand to help you make the right choice.\n\u25cf\tWhat to do early in the process of product design and development to be sure you\u2019re on the right track long before you get to the production phase.\n\u25cf\tWhy it\u2019s vital to keep the 60601 standard in mind, not only when it comes to meeting the standards, but also when it comes to patient safety.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/e64721e5-80f9-4796-a0da-202bc5282be8/41ddd6e8-3e3c-42ec-b23b-1a49856508ea.jpg"}