{"id":7632,"date":"2024-08-07T21:08:23","date_gmt":"2024-08-07T21:08:23","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7632"},"modified":"2024-08-07T21:08:25","modified_gmt":"2024-08-07T21:08:25","slug":"how-to-id-applicable-standards-combinate-podcast","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2024\/08\/07\/how-to-id-applicable-standards-combinate-podcast\/","title":{"rendered":"How to ID Applicable Standards – Combinate Podcast"},"content":{"rendered":"\n

 <\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

Join me, <\/a>Leonard (Leo) Eisner<\/a>, the “IEC 60601 Guy”,

in a conversation with <\/a>Subhi Saadeh<\/a> of Combinate Podcast<\/a>

as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast<\/a> 148 https:\/\/bit.ly\/LIPostCombinatePodcast148LeoEisner<\/a><\/p>\n\n\n\n

He really does his research and is a great interviewer. I always find it fun and intriguing to have a conversation with Subhi<\/a> as I too learn from our conversations.<\/p>\n\n\n\n

We discuss:
\u261e complexities in assessing applicable standards
\u261e understanding the impact of product environment, intended use, & applicable markets
\u261e challenges and strategies for documenting standards assessments
\u261e leveraging existing standards to avoid unnecessary development
\u261e tips for small and large companies
\u261e significance of early research
\u261e essential stakeholders involved in standards assessment
\u261e and more….<\/p>\n\n\n\n

Join us \ud83e\udef5 in the conversation on LinkedIn<\/a> and leave your comments<\/a> so we can continue this discussion<\/a>. <\/p>\n\n\n\n

Need help with 60601 series standards (Medical Electrical Equipment) 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, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner<\/a> is an expert on standards development and sits on many standards committees<\/a>. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. <\/p>\n\n\n\n

We work with many test labs for Medical Safety & 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

Feel free to schedule a call with Leo<\/a> or contact Leo at Leo@EisnerSafety.com or through our contact form<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Join me, Leonard (Leo) Eisner, the “IEC 60601 Guy”,<\/p>\n

in a conversation with Subhi Saadeh of Combinate Podcast<\/p>\n

as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148 <\/p>\n","protected":false},"author":4,"featured_media":7634,"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":[1535,1433,1532,1402,1425,1517,1386,1325,1510,1533,1397,1398,1403,1440,1502,1539,1520,1443,1503,1445,1442,1466,1410,1365,1382,1344,1441,1537,1389,1451,1367,1394,1501,1534,1378,1528,1487,1486,1536,1519,1531,1424,1518,1439,1427,1538,1459,1396,1370,1461,1369,1429,1381,1497,1390,1523,1347,1431,1522,1521,1498,1444,1435,1391,1368,1492,1524,1527,1525],"tags":[],"class_list":["post-7632","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-1535","category-1433","category-1532","category-1402","category-15223-1","category-1517","category-60601-series","category-60601-1","category-60601-1-4th-edition","category-1533","category-1397","category-1398","category-62366-1","category-active-implants","category-architecture-specification","category-aug-2024","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-guidance","category-guidance-documents","category-hamonised-standards","category-harmonized-standards","category-iec","category-iec-60601-1","category-iec-61010","category-imdrf","category-information-provided-by-the-manufacturer","category-interpretation-sheet-1","category-ish1","category-iso-10993","category-iso-13485","category-iso-14708","category-iso-15223-1","category-iso-20417","category-ivd","category-labeling","category-law","category-marking","category-mdd","category-mdr","category-medical-device","category-medical-device-regulation","category-mhra","category-notified-bodies","category-pems","category-podcast","category-quality-assurance","category-recognized-consensus-standards","category-regulation","category-regulatory-affairs","category-risk-management","category-samd","category-software","category-standards","category-standards-development","category-state-of-the-art","category-us","category-usability","category-usability-engineering-process","category-user-interfaces"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7632","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=7632"}],"version-history":[{"count":6,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7632\/revisions"}],"predecessor-version":[{"id":7639,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7632\/revisions\/7639"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/7634"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=7632"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=7632"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=7632"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}