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	<title>ISO 14708 &#8211; Eisner Safety Consultants</title>
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	<item>
		<title>What&#8217;s NASA &#038; Star Trek have to do with IEC 60601?</title>
		<link>https://eisnersafety.com/2025/11/29/whats-nasa-star-trek-have-to-do-with-iec-60601/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=whats-nasa-star-trek-have-to-do-with-iec-60601</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Sat, 29 Nov 2025 05:19:05 +0000</pubDate>
				<category><![CDATA[60601 Series]]></category>
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					<description><![CDATA[From NASA to IEC 60601 - A Lifelong Trek for Safer Devices.

When I was in high school, I had no idea a simple work study opportunity would redirect my entire future. That is exactly what happened when I was beamed over to NASA for the first time. That early exposure to real world engineering lit a spark that has stayed with me ever since. A curiosity for science, safety, and how technology can genuinely serve people.

All these decades later, that same curiosity still energizes my work with IEC 60601, patient safety, and supporting the MedTech industry. So when I joined Faisal Kamal on The ⭕️ Podcast, it felt like a perfect chance to bring all these threads together. Star Trek. NASA. Standards. Innovation. Human factors. EMS &#038; Home use environments.. And above all, patient safety.]]></description>
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    <p>
      When I was in high school, I had no idea a simple work study opportunity would redirect my entire future. That is exactly what happened when I was beamed over to NASA for the first time. That early exposure to real world engineering lit a spark that has stayed with me ever since. A curiosity for science, safety, and how technology can genuinely serve people.
    </p>

    <p>
      All these decades later, that same curiosity still energizes my work with IEC 60601, patient safety, and supporting the MedTech industry. So when I joined Faisal Kamal on The <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/2b55.png" alt="⭕" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Podcast, it felt like a perfect chance to bring all these threads together.
      Star Trek. NASA. Standards. Innovation. Human factors. EMS &amp; Home use environments.. And above all, patient safety.
    </p>

    <p>
      Judging by the conversation that unfolded across LinkedIn afterward, I was not the only one who felt the episode combined heart, humor, and hard won lessons in a very different way.
    </p>

    <h3>Standards Are Not Rulebooks. They Are Star Maps.</h3>

    <p>
      One of the core themes Faisal and I explored on the podcast was the idea that IEC 60601 is not just a set of rules. It is a star map.
    </p>

    <p>
      A star map built from decades of engineering mistakes, test data, regulatory learning, and field experience.
    </p>

    <p>
      Many people see standards as obstacles. In reality, standards like the IEC 60601 series are a knowledge base created to unlock innovation safely, not shut it down.
    </p>

    <p>
      Several people who reacted to the episode picked up on that idea. They commented on how the format allowed serious topics like risk, essential performance, and compliance to feel more approachable. That mix of education and entertainment was exactly what we were hoping for.
    </p>

    <h3>Why Star Trek Got So Much Right</h3>

    <p>
      A fun part of the episode, and something listeners responded to strongly, was connecting Star Trek’s fictional tools to real world design challenges.
    </p>

    <p>
      Take the tricorder.
      It is a great analogy for electronic medical devices used in the home and in EMS environments. These are unpredictable spaces filled with:
    </p>

    <ul>
      <li>noise</li>
      <li>chaotic motion</li>
      <li>temperature shifts</li>
      <li>RF interference</li>
      <li>unexpected stress</li>
    </ul>

    <p>
      The 4th edition of IEC 60601 intentionally integrates these concepts. It pushes engineers and manufacturers to design for the environments where devices actually get used, not just for clean lab conditions.
    </p>

    <p>
      The underlying idea is simple and powerful. Reliability under stress is at the heart of essential performance and patient safety.
    </p>

    <h3>The Human Side Of Standards Work</h3>

    <p>
      Another meaningful thread that came out in the comments was the human side of the story.
    </p>

    <p>
      People commented that the journey from NASA to MedTech felt inspiring and very real. Hearing that from respected peers in the MedTech community meant a lot to me personally.
    </p>

    <p>
      IEC 60601 discussions rarely highlight the human side of standards work. The early influences. The mentors. The choices that move someone from pure engineering into safety and compliance. Those pieces matter.
    </p>

    <p>
      As Faisal noted, learning about the path from NASA to medical device safety helped make the technical content more relatable and more human.
    </p>

    <h3>Building The Next Generation Of Standards Developers</h3>

    <p>
      A theme that resonated with several colleagues, including Beat Keller and others who shared or commented, was the hope that this episode reaches the “Next Generation” of engineers and standards enthusiasts.
    </p>

    <p>
      Right now, more experts are aging out of standards development than new people are joining. The future of safe medical device design depends on bringing younger professionals into the process.
    </p>

    <p>
      If even a handful of listeners feel curious enough to explore standards work after hearing this episode, that is a tremendous win not only for me personally but for the whole MedTech industry as a whole. We desperately need “new blood” to come into standards development.
    </p>

    <h3>A Community Effort</h3>

    <p>
      Many colleagues across LinkedIn reposted, amplified, and commented on the podcast. I am grateful for every one of them.
    </p>

    <p>
      From Trekkie references
      to technical reflections
      to notes from people who simply enjoyed the story
    </p>

    <p>
      the engagement showed how enthusiastic and thoughtful the MedTech safety community really is.
    </p>

    <h3>Where To Listen</h3>

    <p>
      If you have not listened yet, I welcome you to take the journey.
    </p>

    <p>
      “The Star Map to the Future with Leo Eisner The IEC 60601 Guy” on The <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/2b55.png" alt="⭕" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Podcast.
    </p>

    <p>
      It mixes sci fi, standards, storytelling, and safety into a format that is both fun and unexpectedly educational to make it edu-tainment.
    </p>

    <p>
      You can listen to the full episode through The <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/2b55.png" alt="⭕" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Podcast and through the episode links shared on my LinkedIn post and on Faisal’s page.
    </p>

    <h3>Closing Thoughts</h3>

    <p>
      Thank you to everyone who listened, commented, shared, or supported the conversation.
    </p>

    <p>
      Here is to curiosity, creativity, and keeping patients safe
      in every environment
      on every device
      across every generation
      whatever race you are
      where ever you are in the galaxy
    </p>

    <p>
      Live Long and Prosper my Friends one and all<br>
      <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f596.png" alt="🖖" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f680.png" alt="🚀" class="wp-smiley" style="height: 1em; max-height: 1em;" />
    </p>

    <p>
      Leonard “Leo” Eisner<br>
      The IEC 60601 Guy
    </p>

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        If this journey from NASA to IEC 60601 resonated with you and you are working on a device that needs to be safe in every environment it touches, my team and I would be honored to help.
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<p></p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>Major changes to IEC 60601-1 are closer than you think</title>
		<link>https://eisnersafety.com/2025/08/15/major-changes-to-iec-60601-1-are-closer-than-you-think/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=major-changes-to-iec-60601-1-are-closer-than-you-think</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Fri, 15 Aug 2025 18:53:33 +0000</pubDate>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7854</guid>

					<description><![CDATA[Once the 4th Edition is published, redesigns and QMS updates will be far more costly.

Direct insights from someone in the development of IEC 60601-1, 4th Edition
Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-large"><img fetchpriority="high" decoding="async" width="1024" height="576" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-1024x576.jpg" alt="" class="wp-image-7855" srcset="https://eisnersafety.com/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-1024x576.jpg 1024w, https://eisnersafety.com/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-300x169.jpg 300w, https://eisnersafety.com/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-768x432.jpg 768w, https://eisnersafety.com/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-1536x864.jpg 1536w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



<p>Once the 4th Edition is published, redesigns and QMS updates will be far more costly.</p>



<p><strong>Direct insights from someone in the development of IEC 60601-1, 4th Edition</strong></p>



<p>Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.</p>



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<p class="has-medium-font-size"><strong>Event Recap – MLVx Friday In-Focus</strong></p>



<p>On Friday, August 15, the <strong>MLVx Friday In-Focus</strong> with <a href="https://www.linkedin.com/in/sean-smith-mlvx/">Sean Smith</a> brought together <a href="https://www.linkedin.com/in/leoeisnersafetyconsultants/">Leonard (Leo) Eisner</a>, <em>The IEC 60601 Guy</em>, and <strong>110+ professionals</strong> from around the globe,  including the UK, Romania, US, France, Switzerland, Germany, Finland, and Pakistan, representing <strong>medtech manufacturers, regulators, test houses, and standards developers</strong>.</p>



<p>We focused on <strong>the impact of IEC 60601-1, 4th Edition</strong>, the global standard that defines safety and essential performance for medical electrical equipment, and what’s coming that many companies are still not prepared for.</p>



<p>The highlight was an <strong>impromptu expert panel</strong> with leaders in <strong>risk management, software, cybersecurity, regulatory submissions, and combination devices</strong>. Together, we tackled questions from every angle, sharing real-world insights on design, testing, and compliance challenges. The discussion showed exactly what’s possible when top experts collaborate to help the industry prepare for disruptive change.</p>



<p><em><strong>(Full presentation available for download at the bottom of this post.)</strong></em></p>



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<p class="has-medium-font-size"><strong>Unlock Your IEC 60601-1 Insider Advantage</strong></p>



<ul class="wp-block-list">
<li><strong>Mitigate Risks:</strong> Spot disruptive changes early, prevent costly redesigns, and align documentation ahead of competitors</li>



<li><strong>Accelerated Compliance:</strong> Seamlessly integrate evolving requirements into your development pipeline</li>



<li><strong>Leadership Insight:</strong> <em>The IEC 60601 Guy</em> and our expert team track areas of interest for your organization based on draft documents</li>



<li><strong>Behind Closed Doors:</strong> Access knowledge while it’s still being developed</li>



<li><strong>Ready to Leap Ahead?</strong> Let’s turn this insider pipeline into your <strong>4th Edition fast-track</strong></li>
</ul>



<p><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f4de.png" alt="📞" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <strong>+1-503-709-8328</strong> <br><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f310.png" alt="🌐" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://www.EisnerSafety.com"><strong>EisnerSafety.com</strong></a> <br><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://eisnersafety.com/schedule-call/"><strong>Schedule a Free 30-Minute Web Meeting</strong></a></p>



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<p>If you missed the live session, this recap and presentation will help you understand what’s coming — and more importantly, how to prepare.</p>



<div data-wp-interactive="core/file" class="wp-block-file"><object data-wp-bind--hidden="!state.hasPdfPreview" hidden class="wp-block-file__embed" data="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/08/MLVx-Impact-of-IEC-60601-1-4th-Ed-FINAL-Vers-2025-08-15-compressed-for-website.pdf" type="application/pdf" style="width:100%;height:600px" aria-label="Embed of MLVx Impact of IEC 60601-1 4th Ed FINAL Vers 2025-08-15 compressed for website."></object><a id="wp-block-file--media-08fc802f-8178-4f7c-a299-3b4b20341790" href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/08/MLVx-Impact-of-IEC-60601-1-4th-Ed-FINAL-Vers-2025-08-15-compressed-for-website.pdf">MLVx Impact of IEC 60601-1 4th Ed FINAL Vers 2025-08-15 compressed for website</a><a href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/08/MLVx-Impact-of-IEC-60601-1-4th-Ed-FINAL-Vers-2025-08-15-compressed-for-website.pdf" class="wp-block-file__button wp-element-button" download aria-describedby="wp-block-file--media-08fc802f-8178-4f7c-a299-3b4b20341790">Download</a></div>



<p></p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>Join me for an Interactive Workshop Identifying Standards, Guidances, &#038; Turn Standards into Your Competitive Advantage @ 10X</title>
		<link>https://eisnersafety.com/2025/03/31/join-me-for-an-interactive-workshop-identifying-standards-guidances-turn-standards-into-your-competitive-advantage-10x/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=join-me-for-an-interactive-workshop-identifying-standards-guidances-turn-standards-into-your-competitive-advantage-10x</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Mon, 31 Mar 2025 22:50:00 +0000</pubDate>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7796</guid>

					<description><![CDATA[Don't make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines

Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions 

Unprepared Risk Management File for Testing:  Risks unnecessary costs due to lack of strategic planning for compliance.

Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays

Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex">
<figure class="wp-block-image size-large"><img decoding="async" width="791" height="1024" data-id="7800" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_1--791x1024.jpg" alt="" class="wp-image-7800" srcset="https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_1--791x1024.jpg 791w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_1--232x300.jpg 232w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_1--768x994.jpg 768w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_1--1187x1536.jpg 1187w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_1-.jpg 1545w" sizes="(max-width: 791px) 100vw, 791px" /></figure>



<figure class="wp-block-image size-full"><img decoding="async" width="1545" height="2000" data-id="7801" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_2.-.jpg" alt="" class="wp-image-7801" srcset="https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_2.-.jpg 1545w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_2.--232x300.jpg 232w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_2.--791x1024.jpg 791w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_2.--768x994.jpg 768w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_2.--1187x1536.jpg 1187w" sizes="(max-width: 1545px) 100vw, 1545px" /></figure>



<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="1545" height="2000" data-id="7797" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_3.jpg" alt="" class="wp-image-7797" srcset="https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_3.jpg 1545w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_3-232x300.jpg 232w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_3-791x1024.jpg 791w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_3-768x994.jpg 768w, https://eisnersafety.com/wp-content/uploads/2025/03/Leo-Eisner-10x-Speaker-Interview_Page_3-1187x1536.jpg 1187w" sizes="auto, (max-width: 1545px) 100vw, 1545px" /></figure>
</figure>



<p class="has-black-color has-text-color has-link-color wp-elements-1ca930ff9980dfbf94e99dfd59154abb">Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the <a href="https://link.eisnersafety.com/2s2H59" target="_blank" rel="noreferrer noopener">10X Medical Device Conference</a> in Newport Beach, Ca on May 7 &#8211; 8, 2025.  Turn Medical Device Standards into Your Competitive Advantage, and discover practical strategies to leverage standards, avoid costly errors, and accelerate your product development cycle.</p>



<p class="has-black-color has-text-color has-link-color wp-elements-652902cf3bcd0a8ac8093591fae87f65">Don&#8217;t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:</p>



<ul class="wp-block-list">
<li class="has-vivid-red-color has-text-color has-link-color has-medium-font-size wp-elements-b9c09d620bb5dc52570eea5d94ad4967"><strong>Late Identification of Applicable Standards: </strong>Leads to expensive redesigns and delayed timelines</li>



<li class="has-vivid-red-color has-text-color has-link-color has-medium-font-size wp-elements-92e09a3fbc20f361b2a1504ba774ffa3"><strong>Ignoring Expert Standards Guidance: </strong>Results in regulatory rejections and costly resubmissions </li>



<li class="has-vivid-red-color has-text-color has-link-color has-medium-font-size wp-elements-13311a3c0e1e605707e6f214c1111800"><strong>Unprepared Risk Management File for Testing: </strong> Risks unnecessary costs due to lack of strategic planning for compliance.</li>



<li class="has-vivid-red-color has-text-color has-link-color has-medium-font-size wp-elements-d429c286ba496d310bf13ab508ead5e7"><strong>Unprepared Regulatory Submissions:</strong> Leads to costly setbacks and market-entry delays</li>



<li class="has-vivid-red-color has-text-color has-link-color has-medium-font-size wp-elements-05791a4db3496e6ec4f39051c74a71c0"><strong>Underestimating Education and Training:</strong> Creates knowledge gaps, increasing errors and compliance risks.</li>
</ul>



<p>I want to thank <a href="http://linkedin.com/in/sean-smith007" data-type="link" data-id="linkedin.com/in/sean-smith007" target="_blank" rel="noreferrer noopener">Sean Smith</a> and his team from 10X for all his help and dedication for putting on this event.  He is doing an amazing job and please contact him if you are interested.</p>



<p class="has-black-color has-text-color has-link-color wp-elements-d2a4aa01a7b35f89b6f1f730415450fd">Need help with standards?</p>



<p class="has-black-color has-text-color has-link-color wp-elements-44257036905f370cf7d6890d4e58986b">We provide support for your design and development process for regulatory submissions.? Eisner Safety Consultants can help by</p>



<ul class="wp-block-list">
<li class="has-black-color has-text-color has-link-color wp-elements-4886a6bdf9a7c485afedcbdaa5dfc7c4">Assisting with strategic compliance planning for your medical electrical product lines, </li>



<li class="has-black-color has-text-color has-link-color wp-elements-6c6f49211eef65bad93425f96d7543df">Providing regulatory support when FDA or a regulator asks technical questions on your submission. </li>



<li class="has-black-color has-text-color has-link-color wp-elements-74eeb23bc7c270ff86ae42dae4ce7446">Identification of applicable standards, laws, regulations, guidances, and directives up front to support your design process effectively.</li>



<li class="has-black-color has-text-color has-link-color wp-elements-b64c5d665cd44f6e3018ce69abc40e95">Design Documentation Reviews providing expert analysis supporting the design development process to avoid unnecessary design and development delays.</li>



<li class="has-black-color has-text-color has-link-color wp-elements-ff4e9e170c2576b8eb7b49d67a492467"> We provide EU, US, and other countries regulatory requirement reviews of standards, laws, directives, and guidance. </li>



<li class="has-black-color has-text-color has-link-color wp-elements-432203c94bd8c176c5352b80e07a0ad3">Providing support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more. </li>



<li class="has-black-color has-text-color has-link-color wp-elements-3c272281ea343763d16d025572ac4ebd">Interfacing with test houses for medical safety, EMC and  arrange other testing. </li>
</ul>



<p>Feel free to schedule a&nbsp;<a href="https://eisnersafety.com/schedule-call/" target="_blank" rel="noreferrer noopener">web meeting with Leo</a>&nbsp;or&nbsp;<a href="https://eisnersafety.com/contact_eisner_safety/" target="_blank" rel="noreferrer noopener">contact us</a>.</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation</title>
		<link>https://eisnersafety.com/2024/09/30/the-most-valuable-asset-we-each-bring-to-the-table-is%e2%81%89%ef%b8%8f-our-unique-experiences-and-innovation/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=the-most-valuable-asset-we-each-bring-to-the-table-is%25e2%2581%2589%25ef%25b8%258f-our-unique-experiences-and-innovation</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Mon, 30 Sep 2024 06:46:00 +0000</pubDate>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7706</guid>

					<description><![CDATA[Leo Eisner, The60601Guy will be visiting London 🇬🇧🎡🏰 in October.  You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct. 

Meet me in London - I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁. I’d love to chat!]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="733" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-1024x733.png" alt="" class="wp-image-7708" style="width:1071px;height:auto" srcset="https://eisnersafety.com/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-1024x733.png 1024w, https://eisnersafety.com/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-300x215.png 300w, https://eisnersafety.com/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-768x550.png 768w, https://eisnersafety.com/wp-content/uploads/2024/10/Are-You-A-MedTech-Co.png 1514w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>



<p>Leo Eisner, <a href="https://www.linkedin.com/feed/hashtag/?keywords=the60601guy&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7241437643480203265" target="_blank" rel="noreferrer noopener">The60601Guy</a> will be visiting London <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f1ec-1f1e7.png" alt="🇬🇧" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f3a1.png" alt="🎡" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f3f0.png" alt="🏰" class="wp-smiley" style="height: 1em; max-height: 1em;" /> in October.  You have the chance to sit down with me, <a href="https://www.linkedin.com/feed/hashtag/?keywords=the60601guy" target="_blank" rel="noreferrer noopener">The60601Guy</a>, have a cup a coffee or a beer and talk <a href="https://www.linkedin.com/feed/hashtag/?keywords=iec60601" target="_blank" rel="noreferrer noopener">IEC60601</a>, design for compliance, and <a href="http://cme.sh/DM7ct7" target="_blank" rel="noreferrer noopener">standards that apply to your device</a>. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct. <br><br>Meet me in London &#8211; I want to hear from you the week of 7 Oct. These <strong>two hour slots</strong> are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 <strong>𝘀𝗽𝗲𝗰𝗶𝗮𝗹 </strong>𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for <a href="https://tidycal.com/the60601guy/meet-leo-in-london" target="_blank" rel="noreferrer noopener">𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁</a>. I’d love to chat!<br><br>Let’s connect, and explore how we can support your company with our international team of compliance &amp; regulatory experts from <a href="https://eisnersafety.com/about_us/associates/" target="_blank" rel="noreferrer noopener">Eisner Safety Consultants</a>. I’m eager to learn what you’re working on and how you’re driving change and innovation in the industry, and how we can support you to get you to market faster.<br><br>Let’s meet up! 𝗕𝗼𝗼𝗸 𝘁𝗶𝗺𝗲 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for <a href="https://tidycal.com/the60601guy/meet-leo-in-london" target="_blank" rel="noreferrer noopener">𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁</a>.<br><br></p>
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		<title>How to ID Applicable Standards &#8211; Combinate Podcast</title>
		<link>https://eisnersafety.com/2024/08/07/how-to-id-applicable-standards-combinate-podcast/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=how-to-id-applicable-standards-combinate-podcast</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Wed, 07 Aug 2024 21:08:23 +0000</pubDate>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7632</guid>

					<description><![CDATA[Join me, Leonard (Leo) Eisner, the "IEC 60601 Guy",

in a conversation with Subhi Saadeh of Combinate Podcast

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 ]]></description>
										<content:encoded><![CDATA[
<p>&nbsp;</p>



<figure class="wp-block-image size-full is-resized"><img loading="lazy" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner.jpeg" alt="" class="wp-image-7634" width="1218" height="1218" srcset="https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner.jpeg 540w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-300x300.jpeg 300w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-150x150.jpeg 150w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-270x270.jpeg 270w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-230x230.jpeg 230w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-45x45.jpeg 45w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-100x100.jpeg 100w" sizes="auto, (max-width: 1218px) 100vw, 1218px" /></figure>



<p>Join me, <a href="https://www.linkedin.com/in/ACoAAABI0MQBuOSm1PL6Rtb3VTU5ORFgMiOgnQ0"></a><a href="https://www.linkedin.com/in/leoeisnersafetyconsultants/" target="_blank" rel="noreferrer noopener">Leonard (Leo) Eisner</a>, the &#8220;IEC 60601 Guy&#8221;,<br><br>in a conversation with <a href="https://www.linkedin.com/in/ACoAAASYqiIBwAoA_1K9vXX-snW26Y7H7REb9kk"></a><a href="https://www.linkedin.com/in/subhi-saadeh-1169aa21/" target="_blank" rel="noreferrer noopener">Subhi Saadeh</a> of <a href="https://www.linkedin.com/company/combinate-podcast/" target="_blank" rel="noreferrer noopener">Combinate Podcast</a><br><br>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 <a href="https://www.linkedin.com/company/combinate-podcast/" target="_blank" rel="noreferrer noopener">Combinate Podcast</a> 148 <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">https://bit.ly/LIPostCombinatePodcast148LeoEisner</a></p>



<p>He really does his research and is a great interviewer.  I always find it fun and intriguing to have a conversation with <a href="https://www.linkedin.com/in/subhi-saadeh-1169aa21/" target="_blank" rel="noreferrer noopener">Subhi</a> as I too learn from our conversations.</p>



<p>We discuss:<br>☞ complexities in assessing applicable standards<br>☞ understanding the impact of product environment, intended use, &amp; applicable markets<br>☞ challenges and strategies for documenting standards assessments<br>☞ leveraging existing standards to avoid unnecessary development<br>☞ tips for small and large companies<br>☞ significance of early research<br>☞ essential stakeholders involved in standards assessment<br>☞ and more&#8230;.</p>



<p>Join us <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1faf5.png" alt="🫵" class="wp-smiley" style="height: 1em; max-height: 1em;" /> in the conversation on <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">LinkedIn</a> and <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">leave your comments</a> so we can <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">continue this discussion</a>. </p>



<p>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, &amp; other country regulatory requirements &amp; standards, laws, directives, and more.&nbsp;<a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a>&nbsp;is an expert on standards development and <a href="https://www.linkedin.com/in/leoeisnersafetyconsultants" target="_blank" rel="noreferrer noopener">sits on many standards committees</a>.&nbsp;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>



<p>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>



<p>Feel free to&nbsp;<a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">schedule a call with Leo</a>&nbsp;or contact Leo at&nbsp;L&#101;o&#64;Eisne&#114;&#83;a&#102;e&#116;&#121;&#46;co&#109;&nbsp;or through our&nbsp;<a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>
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