{"id":4871,"date":"2016-11-23T21:47:48","date_gmt":"2016-11-23T21:47:48","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4871"},"modified":"2022-06-12T18:24:03","modified_gmt":"2022-06-12T18:24:03","slug":"tips-for-success-when-it-comes-to-iec-60601-1-podcast","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2016\/11\/23\/tips-for-success-when-it-comes-to-iec-60601-1-podcast\/","title":{"rendered":"Tips for Success When It Comes to IEC 60601-1 – Podcast"},"content":{"rendered":"

Jon Speer, founder and VP of QA\/RA @ greenlight.guru<\/a> and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a dynamic & interesting\u00a0conversation that we are sharing as a podcast with you\u00a0on tips for success when it comes to IEC 60601-1<\/a>.<\/p>\n

\"iec_60601-1_leo_eisner_podcast\"<\/a>Eisner Safety Consultants\u00a0has teamed up with greenlight.guru<\/a>, a specialized electronic Quality Management System (eQMS) platform specifically designed for small to\u00a0mid-size Medical Device companies. greenlight.guru<\/a> will\u00a0reduce your quality management system overhead, a web based system, which is easy and practical to use, will minimize your paper trail, and consequently your need for excessive consultant hours allowing you to focus on your product and getting to market. greenlight.guru<\/a> and Eisner Safety Consultants\u00a0are both well equipped with our\u00a0specialized expertise and know how to get your device to market, and more importantly \u2013 STAY in market!<\/p>\n

IEC 60601-1 is the gold standard for electrical medical devices around the world. IEC 60601 is a challenge for many companies that are developing electronic medical devices. \u00a0It\u2019s wise to have a guide to help you understand and work through the process, and in this podcast\u00a0I discuss with Jon Speer some\u00a0guidance you can use.<\/p>\n

You need to understand why this standard series is\u00a0important when developing your electrical medical products for your regulatory submissions. You need to know what they are (join our\u00a0webinar on the 15 Steps to Get IEC 60601-1 Approval<\/a> on Dec 13, 2016 to get more details) and understanding how to incorporate them as part of your design and development process at the beginning rather at the end of the process.<\/p>\n

Listen Now:<\/em><\/h4>\n

[soundcloud url=”https:\/\/api.soundcloud.com\/tracks\/294258926″ params=”color=00cc11&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false” width=”100%” height=”166″ iframe=”true” \/]<\/p>\n

In the Podcast<\/a> Leo & Jon discuss:<\/em><\/p>\n

\u25cf What makes the 60601 process different from the other regulatory compliance processes.<\/p>\n

\u25cf Some 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.<\/p>\n

\u25cf Tips on preparing for success when creating a timeline for getting through the 60601 process, as well as some of the steps involved.<\/p>\n

\u25cf Differences between different types of safety labs and the criteria that\u2019s vital to understand to help you make the right choice.<\/p>\n

\u25cf What 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.<\/p>\n

\u25cf Why 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.<\/p>\n

\u25cf The Annual Standards Trend Reports<\/a> (click to get a sample report now & our new pricing)<\/a>\u00a0and how you\u00a0can benefit your company and save money and time.<\/p>\n

\u201cGive yourself a buffer. There will be bumps in the road… guaranteed.<\/em>\u201d \u00a0\u201cSome labs know medical very well, and there are a lot that don\u2019t.<\/em>\u201d\u00a0– Leo Eisner<\/em><\/em><\/p>\n

A recommendation I tell my clients: When it comes to developing products to the IEC 60601 series of standards is that you need to\u00a0know your product well enough to\u00a0determine\u00a0what standards apply early in the development process – from there you\u2019ll know how much preparation and testing it will take. \u00a0If this is something you don’t have the expertise or the bandwidth for we can do it for you. \u00a0One tool I recommend for my clients is we can provide you with our Annual Standards Trend Reports<\/a> (click for a sample report & our new pricing)<\/a>\u00a0so you are strategically positioned for the changes that are coming, the new standards in development and for the recently released standards you didn’t even know exist. \u00a0View a sample of our Annual Standards Trend Reports\u00a0& our new pricing<\/a>. \u00a0The Annual Standards Trend Reports<\/a> can to help you navigate the standards\u00a0that apply to\u00a0you and save you a lot of money and time.<\/p>\n

About The Global Medical Device Podcast<\/a>:<\/h6>\n

\"\"<\/a>The Global Medical Device Podcast<\/a> powered by greenlight.guru<\/a> is where today’s brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world’s leading medical device experts and companies.<\/p>\n

Like this episode? Subscribe today on iTunes<\/a>, Sticher<\/a> or SoundCloud<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Jon Speer, founder and VP of QA\/RA @ greenlight.guru and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a dynamic & interesting\u00a0conversation that we are sharing as a podcast with you\u00a0on tips for success when it comes to<\/p>\n","protected":false},"author":4,"featured_media":4872,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[1312,61,15,16,63,27,10,88,89,53,94,95,12,330,1313],"class_list":["post-4871","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-601-guy","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-en60601","tag-escnews","tag-fda-guidance","tag-home-use","tag-home-use-environment","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-iec60601-1-11","tag-mdd","tag-medical-device","tag-the-60601-1-guy"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4871","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=4871"}],"version-history":[{"count":1,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4871\/revisions"}],"predecessor-version":[{"id":7268,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4871\/revisions\/7268"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=4871"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=4871"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=4871"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}