{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F8927ca50-b4ea-4b91-aa92-6b61c4cd5b84","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"How to Design for Compliance with IEC 60601","description":"Have you ever designed a medical device that has electrical components? Was it frustrating to go through the electrical safety testing - the IEC 60601 standards?\n\nClaus Roemer Andersen, a compliance expert from Roemer Consulting, shares his experiences and advises us on how to design for compliance with IEC 60601.\n\nAfter all, a lack of electrical compatibility can be detrimental to medical devices and the patients who use them.\n\nIEC 60601 documentation is a lot to digest, which is a major challenge. But that does not mean you should neglect those standards. Applying the standards and making changes early on adds value and saves your company a lot of money.\n\nSome of the Highlights of the show include: \n\n-Road to Compliance: Design specific technical requirements during the early phases of product development, and perform design reviews and pre-testing.\n-How to integrate design input requirements from a risk-management perspective.\n-Why IEC 60601 standards are difficult for most people to navigate.\nIEC 60601 has 8 specific things you have to address in your risk-management process, but they don\u2019t fit into or make sense in a typical risk analysis table.\n-The reason why the FMEA tool is not a useful tool regarding electrical safety: It is a single-fault failure, which is not sufficient.\n-Understand who will be using a product and in what kind of environments because that shapes what you need to do regarding electrical safety.\n-If you don\u2019t follow standards, you face expensive and time-consuming redesign or you have to defend the effectiveness of your risk analysis.\n-The days of \u201cI Promise\u201d statements for electrical safety are gone, and they make for delays and redesign challenges.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/3c0cd4da-0063-4a72-8684-ac42fe52dcb6/a17fe835-74de-4fcd-a4a2-ea66230dc1a6.png"}