{"id":8354,"date":"2025-10-19T00:04:30","date_gmt":"2025-10-19T00:04:30","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=8354"},"modified":"2025-10-19T00:04:30","modified_gmt":"2025-10-19T00:04:30","slug":"from-engineer-to-the-iec-60601-guy-project-medtech-podcast","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2025\/10\/19\/from-engineer-to-the-iec-60601-guy-project-medtech-podcast\/","title":{"rendered":"From Engineer To \u201cThe IEC 60601 Guy\u201d &#8211; Project MedTech Podcast"},"content":{"rendered":"\n<!-- === Eisner Safety Consultants Blog Theme Styles (v7) === -->\n<style>\n:root{\n  --esc-primary:#004c91; --esc-accent:#118bee; --esc-ink:#1b1f23;\n  --esc-muted:#6b7280; --esc-bg:#ffffff; --esc-card:#f7fafc;\n  --esc-border:#e5e7eb; --esc-shadow:0 6px 18px rgba(0,0,0,.06);\n  --esc-radius:18px;\n  --esc-spotify-bg:#eef6ff; --esc-spotify-bd:#d6e8ff;\n}\nhtml{scroll-behavior:smooth;}\n.esc-wrap{font-family:system-ui,-apple-system,Segoe UI,Roboto,Inter,Arial,sans-serif;color:var(--esc-ink);line-height:1.6;background:var(--esc-bg);}\n.esc-hero{\n  display:grid;gap:1.25rem;grid-template-columns:1fr;\n  padding:2rem;border:1px solid var(--esc-border);border-radius:var(--esc-radius);\n  background:linear-gradient(180deg,#f9fbff 0,#fff 100%);box-shadow:var(--esc-shadow);\n}\n.esc-eyebrow{font-size:.82rem;letter-spacing:.08em;text-transform:uppercase;color:var(--esc-muted);}\n.esc-title{font-size:clamp(1.6rem,2.2vw,2.2rem);font-weight:800;margin:.25rem 0;color:var(--esc-primary);}\n.esc-sub{color:var(--esc-muted);font-size:1rem;margin:.25rem 0 .75rem;}\n.esc-img{border-radius:var(--esc-radius);width:100%;height:auto;box-shadow:var(--esc-shadow);align-self:start;}\n.esc-meta{font-size:.92rem;color:var(--esc-muted);margin:0;}\n\n.esc-apple-embed{grid-column:1 \/ -1;margin-top:.25rem;}\n.esc-cta{display:flex;flex-wrap:wrap;gap:.5rem;margin-top:.6rem;justify-content:center}\n.esc-btn{appearance:none;border:1px solid transparent;border-radius:999px;padding:.7rem 1.05rem;font-weight:700;cursor:pointer;text-decoration:none;\ndisplay:inline-flex;align-items:center;justify-content:center;gap:.5rem;box-shadow:var(--esc-shadow);min-width:160px}\n.esc-btn--primary{background:var(--esc-primary);color:#fff;border-color:var(--esc-primary)}\n.esc-btn--soft{background:var(--esc-spotify-bg);color:var(--esc-primary);border-color:var(--esc-spotify-bd)}\n\n.esc-section{margin:2rem 0}\n.esc-h2{font-size:1.3rem;font-weight:800;color:var(--esc-primary);margin:0 0 .75rem}\n.esc-quote{border-left:4px solid var(--esc-primary);padding:.75rem 1rem;margin:.8rem 0;background:#fff;border-radius:12px}\n.esc-quote cite{display:block;margin-top:.4rem;color:var(--esc-muted);font-style:normal}\n\n\/* \u2705 tightened hanging-indent checklist *\/\n.esc-checklist{margin:.75rem 0;}\n.esc-check{\n  position:relative;\n  margin:.55rem 0 .55rem 3rem;   \/* overall indent *\/\n  padding-left:1rem;             \/* tighter space between checkmark & text *\/\n  text-indent:0;\n  line-height:1.6;\n}\n.esc-check::before{\n  content:\"\u2705\";\n  position:absolute;\n  left:-1rem;                    \/* moves checkmark closer to text *\/\n  top:0;\n}\n\n@media(min-width:900px){\n  .esc-hero{grid-template-columns:1.2fr .9fr;align-items:start}\n  .esc-apple-embed{grid-column:1 \/ -1}\n}\n<\/style>\n\n<article class=\"esc-wrap\">\n  <!-- HERO -->\n  <section class=\"esc-hero\">\n    <div>\n      <div class=\"esc-eyebrow\">Podcast Feature<\/div>\n      <h1 class=\"esc-title\">From engineer to \u201cThe IEC 60601 Guy\u201d \u2014 my story and practical tips<\/h1>\n      <p class=\"esc-sub\">\n        I joined <strong>Duane Mancini<\/strong> on the <strong>Project Medtech Podcast<\/strong> to share how I became known for IEC 60601,\n        why the series is a roadmap you can follow, and what 4th Edition changes mean for design, QMS, and documentation.\n      <\/p>\n      <p class=\"esc-meta\">Episode 235<\/p>\n    <\/div>\n\n    <div>\n      <img decoding=\"async\" class=\"esc-img\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2025\/10\/Episode-235-Leo-Eisner-scaled.png\" alt=\"Project Medtech Podcast Episode 235 \u2013 Leo Eisner\">\n    <\/div>\n\n    <div class=\"esc-apple-embed\">\n      <iframe allow=\"autoplay *; encrypted-media *; fullscreen *\" frameborder=\"0\" height=\"175\"\n        style=\"width:100%;max-width:100%;overflow:hidden;border-radius:12px;\"\n        sandbox=\"allow-forms allow-popups allow-same-origin allow-scripts allow-top-navigation-by-user-activation\"\n        src=\"https:\/\/embed.podcasts.apple.com\/us\/podcast\/episode-235-leo-eisner-founder-and-principal\/id1513851432?i=1000730356742\">\n      <\/iframe>\n\n      <div class=\"esc-cta\">\n        <a class=\"esc-btn esc-btn--primary\" href=\"https:\/\/pod.wave.co\/podcast\/project-medtech\/episode-235-leo-eisner-founder-and-principal-compliance-regulatory-consultant-of-eisner-safety-consu\" target=\"_blank\">Listen on Web<\/a>\n        <a class=\"esc-btn esc-btn--soft\" href=\"https:\/\/open.spotify.com\/episode\/7FanaVyIKfv4PaBkuWgZ5X\" target=\"_blank\">Open Spotify<\/a>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- PERSONAL INTRO -->\n  <section class=\"esc-section\">\n    <h2 class=\"esc-h2\">A quick personal note<\/h2>\n    <p>\n      Nobody starts at the top as \u201cThe IEC 60601 Guy.\u201d My path ran through early days at NASA, many years in test labs,\n      and deep work in standards committees. What stuck with me is simple \u2014 <strong>stay curious<\/strong>,\n      <strong>do the work<\/strong>, and <strong>show the work<\/strong>. That\u2019s how we turn a dense standard into a practical plan.\n    <\/p>\n  <\/section>\n\n  <!-- KEY TAKEAWAYS -->\n  <section class=\"esc-section\">\n    <h2 class=\"esc-h2\">Key takeaways from the episode<\/h2>\n    <p>\n      On the Project Medtech Podcast with Duane Mancini, M. Sc., I shared my <strong>genesis story<\/strong> of how I became known as The \u201cIEC 60601 Guy\u201d.\n      Duane asked me to give listeners a <strong>101 course<\/strong> on the IEC 60601 series, and I explained how I strive to\n      \u201cde-Greek\u201d or demystify the standard series, and gave a preview of the <strong>big shifts coming in 4th Edition<\/strong>.\n    <\/p>\n\n    <div class=\"esc-checklist\">\n      <p class=\"esc-check\">The \u201cbig picture\u201d structure of the <strong>general standard<\/strong>, <strong>collateral standards<\/strong>, and <strong>particular standards<\/strong><\/p>\n      <p class=\"esc-check\">How <strong>lifecycle standards<\/strong> (risk management, usability, software) compare to <strong>type test standards<\/strong> in the 60601 family<\/p>\n      <p class=\"esc-check\"><strong>Tangible changes<\/strong> to watch in the upcoming <strong>4th Edition<\/strong>: clearer alarm requirements and impacts on design, QMS, &amp; documentation<\/p>\n      <p class=\"esc-check\">Why <strong>leaning on experts<\/strong> (internal or external) is key to getting this right for the impacts of 4th Edition<\/p>\n      <p class=\"esc-check\">My goal is to <strong>\u201cde-Greek\u201d the process<\/strong> and show that IEC 60601 can be a <strong>roadmap<\/strong> \ud83d\uddfa\ufe0f, not a riddle<\/p>\n    <\/div>\n\n    <p>\n      Whether you\u2019re new to standards or a seasoned MedTech veteran, this episode shows how to approach IEC 60601 as a <strong>roadmap you can follow<\/strong>,\n      instead of a riddle you can never quite solve.\n    <\/p>\n  <\/section>\n\n  <!-- QUOTES -->\n  <section class=\"esc-section\">\n    <h2 class=\"esc-h2\">What peers said<\/h2>\n    <div class=\"esc-quote\">\n      <p>\u201cIf you want to know more about IEC 60601, Leo is the resource to go to \u2026 I recommend this episode to everybody working with medical electrical equipment.\u201d<\/p>\n      <cite>\u2014 Beat Keller<\/cite>\n    <\/div>\n    <div class=\"esc-quote\">\n      <p>\u201cGreat to see how you became such an expert \u2026 I hope your story inspires young professionals to invest in becoming experts themselves.\u201d<\/p>\n      <cite>\u2014 Ronald Boumans<\/cite>\n    <\/div>\n    <div class=\"esc-quote\">\n      <p>\u201cIt\u2019s amazing that you covered the difference between process and test standards \u2014 there\u2019s still a lot of confusion out there.\u201d<\/p>\n      <cite>\u2014 Tibor Zechmeister<\/cite>\n    <\/div>\n  <\/section>\n\n  <!-- CONTINUE DISCUSSION -->\n  <section class=\"esc-section\">\n    <p>\n      <a href=\"https:\/\/www.linkedin.com\/posts\/leoeisnersafetyconsultants_medtech-medicaldevices-iec60601-activity-7381360523105415168-uuJq?utm_source=share&#038;utm_medium=member_desktop&#038;rcm=ACoAAABI0MQBuOSm1PL6Rtb3VTU5ORFgMiOgnQ0\" target=\"_blank\">\n        Continue the discussion on this topic on LinkedIn\n      <\/a>\n    <\/p>\n  <\/section>\n\n  <!-- HOW WE CAN HELP -->\n  <section class=\"esc-section\">\n    <h2 class=\"esc-h2\">How We Can Help<\/h2>\n    <p>\n      If your team needs help with the IEC 60601 Series, or mapping the 4th Edition into your design controls, QMS, labeling, or testing strategy,\n      my team at <strong>Eisner Safety Consultants<\/strong> and I are ready to support you.\n    <\/p>\n    <p style=\"text-align:center;\">\n      <a class=\"esc-btn esc-btn--primary\" href=\"https:\/\/eisnersafety.com\/schedule-call\/\" target=\"_blank\">\n        Schedule a call with me, Leo, the IEC 601 Guy\n      <\/a>\n    <\/p>\n  <\/section>\n<\/article>\n","protected":false},"excerpt":{"rendered":"<p>From engineer to \u201cThe IEC 60601 Guy\u201d \u2014 my story and practical tips<br \/>\nI joined Duane Mancini on the Project Medtech Podcast to share how I became known for IEC 60601, why the series is a roadmap you can follow, and what 4th Edition changes mean for design, QMS, and documentation.<\/p>\n<p>A quick personal note<br \/>\nNobody starts at the top as \u201cThe IEC 60601 Guy.\u201d My path ran through early days at NASA, many years in test labs, and deep work in standards committees. What stuck with me is simple \u2014 stay curious, do the work, and show the work. That\u2019s how we turn a dense standard into a practical plan.<\/p>\n","protected":false},"author":4,"featured_media":8356,"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":[1386,1325,1357,1350,1358,1353,1421,1355,1354,1356,1510,1397,1398,1403,1481,1514,1526,1502,1520,1443,1493,1503,1445,1466,1410,1344,1499,1394,1501,1378,1528,1487,1486,1395,1536,1424,1518,1427,1459,1396,1370,1461,1369,1549,1381,1556,1497,1446,1390,1347,1431,1522,1521,1498,1508,1411,1444,1435,1391,1368,1492,1524,1527,1525],"tags":[],"class_list":["post-8354","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-60601-series","category-60601-1","category-60601-1-10","category-60601-1-11","category-60601-1-12","category-60601-1-2","category-60601-1-2-ed-4-1","category-60601-1-6","category-60601-1-8","category-60601-1-9","category-60601-1-4th-edition","category-1397","category-1398","category-62366-1","category-aami","category-ai","category-alarm-systems","category-architecture-specification","category-combination-device","category-combination-product","category-cybersecurity","category-design-specification","category-device","category-emc","category-essential-performance","category-fda","category-hazards","category-iec","category-iec-60601-1","category-imdrf","category-information-provided-by-the-manufacturer","category-interpretation-sheet-1","category-ish1","category-iso","category-iso-10993","category-iso-15223-1","category-iso-20417","category-labeling","category-marking","category-mdd","category-mdr","category-medical-device","category-medical-device-regulation","category-medtech","category-notified-bodies","category-oct-2025","category-pems","category-physiologic-closed-loop-control","category-podcast","category-recognized-consensus-standards","category-regulation","category-regulatory-affairs","category-risk-management","category-samd","category-simd","category-single-fault-condition","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\/8354","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=8354"}],"version-history":[{"count":10,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/8354\/revisions"}],"predecessor-version":[{"id":8365,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/8354\/revisions\/8365"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/8356"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=8354"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=8354"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=8354"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}