{"id":7686,"date":"2024-09-25T01:00:00","date_gmt":"2024-09-25T01:00:00","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7686"},"modified":"2024-10-01T00:03:45","modified_gmt":"2024-10-01T00:03:45","slug":"what-standards-apply-to-my-device-podcast-383","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2024\/09\/25\/what-standards-apply-to-my-device-podcast-383\/","title":{"rendered":"What Standards Apply to My Device? Podcast #383"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"939\" height=\"1024\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/09\/Screenshot-2024-09-26-at-10.20.09\u202fAM-939x1024.png\" alt=\"\" class=\"wp-image-7685\" style=\"aspect-ratio:0.9171686746987951;width:957px;height:auto\" srcset=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/09\/Screenshot-2024-09-26-at-10.20.09\u202fAM-939x1024.png 939w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/09\/Screenshot-2024-09-26-at-10.20.09\u202fAM-275x300.png 275w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/09\/Screenshot-2024-09-26-at-10.20.09\u202fAM-768x838.png 768w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2024\/09\/Screenshot-2024-09-26-at-10.20.09\u202fAM.png 1104w\" sizes=\"auto, (max-width: 939px) 100vw, 939px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udce3\ud83d\udce3 \ud835\uddea\ud835\uddf5\ud835\uddee\ud835\ude01 \ud835\udde6\ud835\ude01\ud835\uddee\ud835\uddfb\ud835\uddf1\ud835\uddee\ud835\uddff\ud835\uddf1\ud835\ude00 \ud835\uddd4\ud835\uddfd\ud835\uddfd\ud835\uddf9\ud835\ude06 \ud835\ude01\ud835\uddfc \ud835\udde0\ud835\ude06 \ud835\uddd7\ud835\uddf2\ud835\ude03\ud835\uddf6\ud835\uddf0\ud835\uddf2? <a href=\"https:\/\/bit.ly\/StdsApplytoMyDvcPodcast\" target=\"_blank\" rel=\"noreferrer noopener\">Podcast<\/a> with one of the best MedTech podcasters <a href=\"https:\/\/www.linkedin.com\/in\/ACoAABLOl1MBgpdtq2ui3hxQ-g4qhSMMczn7foE\"><\/a><a href=\"https:\/\/www.linkedin.com\/in\/etiennenichols\/\" target=\"_blank\" rel=\"noreferrer noopener\">Etienne Nichols<\/a> &#8211; <a href=\"https:\/\/www.linkedin.com\/company\/greenlight-guru\/\" target=\"_blank\" rel=\"noreferrer noopener\">Greenlight Guru<\/a>&#8216;s very own\ud83d\ude0e\ud83c\udf89<br><br>\ud835\uddde\ud835\uddf2\ud835\ude06 \ud835\udde7\ud835\uddfc\ud835\uddfd\ud835\uddf6\ud835\uddf0\ud835\ude00:\u203c\ufe0f<br>\u2022 Why standards like <a href=\"https:\/\/www.linkedin.com\/feed\/hashtag\/?keywords=iec60601&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7245128762487406592\" target=\"_blank\" rel=\"noreferrer noopener\">IEC60601<\/a> are crucial for medical device development<br>\u2022 Steps for identifying proper standards for your product<br>\u2022 How to integrate standards into your design process<br>\u2022 Mistakes &amp; consequences of ignoring standards<br>\u2022 Tools for staying updated on changing standards &amp; regulations<br>\u2022 How startups can navigate standards with limited resources<br><br>If you have any thoughts and comments on the <a href=\"https:\/\/bit.ly\/StdsApplytoMyDvcPodcast\" target=\"_blank\" rel=\"noreferrer noopener\">podcast<\/a> I&#8217;d would like to hear from you \ud83e\udef5 Comment on the <a href=\"https:\/\/bit.ly\/StdsApplyDvcsPodcastLI\" target=\"_blank\" rel=\"noreferrer noopener\">LinkedIn post about the Podcast<\/a><br><br>If you found this interesting or helpful, consider Reposting \ud83d\udd04 on LinkedIn; follow me, <a href=\"https:\/\/bit.ly\/LeoEisnerLinkedInProfile\" target=\"_blank\" rel=\"noreferrer noopener\">Leonard (Leo) Eisner<\/a>, <a href=\"https:\/\/www.linkedin.com\/feed\/hashtag\/?keywords=the60601guy&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7245128762487406592\" target=\"_blank\" rel=\"noreferrer noopener\">the60601Guy<\/a> and click the \ud83d\udd14 so you don&#8217;t miss future content.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Need help with 60601 series standards including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, &amp; other country regulatory requirements &amp; standards, laws, directives, and more.\u00a0Eisner Safety Consultants\u00a0<a href=\"https:\/\/eisnersafety.com\/about_us\/associates\/\" target=\"_blank\" rel=\"noreferrer noopener\">team of experts<\/a>\u00a0also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more.\u00a0His team includes experts on additional standards committees and we all talk to the regulators regularly. We\u2019re here to support your needs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We work with many test labs for Medical Safety &amp; EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Feel free to&nbsp;<a rel=\"noreferrer noopener\" href=\"http:\/\/www.eisnersafety.com\/Schedule-Call\/\" target=\"_blank\">schedule a web meeting with Leo<\/a>&nbsp;or contact Leo at&nbsp;Leo@EisnerSafety.com&nbsp;or through our&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/eisnersafety.com\/contact_eisner_safety\/\" target=\"_blank\">contact form<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\ud835\uddea\ud835\uddf5\ud835\uddee\ud835\ude01 \ud835\udde6\ud835\ude01\ud835\uddee\ud835\uddfb\ud835\uddf1\ud835\uddee\ud835\uddff\ud835\uddf1\ud835\ude00 \ud835\uddd4\ud835\uddfd\ud835\uddfd\ud835\uddf9\ud835\ude06 \ud835\ude01\ud835\uddfc \ud835\udde0\ud835\ude06 \ud835\uddd7\ud835\uddf2\ud835\ude03\ud835\uddf6\ud835\uddf0\ud835\uddf2? Podcast with one of the best MedTech podcasters Etienne Nichols &#8211; Greenlight Guru&#8217;s very own<\/p>\n<p>\ud835\uddde\ud835\uddf2\ud835\ude06 \ud835\udde7\ud835\uddfc\ud835\uddfd\ud835\uddf6\ud835\uddf0\ud835\ude00:\u203c\ufe0f<br \/>\n\u2022 Why standards like IEC60601 are crucial for medical device development<br \/>\n\u2022 Steps for identifying proper standards for your product<br \/>\n\u2022 How to integrate standards into your design process<br \/>\n\u2022 Mistakes &#038; consequences of ignoring standards<br \/>\n\u2022 Tools for staying updated on changing standards &#038; regulations<br \/>\n\u2022 How startups can navigate standards with limited resources<\/p>\n","protected":false},"author":4,"featured_media":7685,"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":[1425,1517,1386,1325,1360,1359,1400,1421,1510,1397,1398,1403,1502,1520,1443,1503,1445,1442,1466,1410,1365,1382,1344,1441,1352,1537,1389,1451,1367,1394,1501,1395,1424,1518,1427,1538,1459,1461,1369,1429,1390,1347,1431,1522,1542,1435,1391,1368,1492],"tags":[],"class_list":["post-7686","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-15223-1","category-1517","category-60601-series","category-60601-1","category-60601-1-a2","category-60601-1-amendment-2","category-60601-1-2-4th-ed","category-60601-1-2-ed-4-1","category-60601-1-4th-edition","category-1397","category-1398","category-62366-1","category-architecture-specification","category-combination-device","category-combination-product","category-design-specification","category-device","category-draft-guidance","category-emc","category-essential-performance","category-eu","category-eu-commission","category-fda","category-final-guidance","category-greenlight-guru","category-guidance","category-guidance-documents","category-hamonised-standards","category-harmonized-standards","category-iec","category-iec-60601-1","category-iso","category-iso-15223-1","category-iso-20417","category-labeling","category-law","category-marking","category-medical-device","category-medical-device-regulation","category-mhra","category-podcast","category-recognized-consensus-standards","category-regulation","category-regulatory-affairs","category-sept-2024","category-standards","category-standards-development","category-state-of-the-art","category-us"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7686","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=7686"}],"version-history":[{"count":8,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7686\/revisions"}],"predecessor-version":[{"id":7696,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7686\/revisions\/7696"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/7685"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=7686"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=7686"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=7686"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}