Combination Device – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Sat, 17 Jan 2026 00:47:11 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Combination Device – Eisner Safety Consultants https://eisnersafety.com 32 32 Medical Device Compliance & Certification Summit – Why It Matters? https://eisnersafety.com/2025/12/23/medical-device-compliance-certification-summit-why-it-matters/?utm_source=rss&utm_medium=rss&utm_campaign=medical-device-compliance-certification-summit-why-it-matters Tue, 23 Dec 2025 23:30:37 +0000 https://eisnersafety.com/?p=8390 /* Wrapper */ .esc-wrap{max-width:980px;margin:0 auto;font-family:inherit} /* Title + intro */ .esc-hero h1{font-size:44px;line-height:1.15;margin:0 0 14px} .esc-hero p{font-size:18px;line-height:1.65;margin:0 0 14px} /* Main image under title */ .esc-mainimg{margin:18px 0 28px} .esc-mainimg img{ display:block; width:100%; max-width:100%; height:auto; border-radius:18px; } /* Super hero info box */ .esc-callout{ background:#EAF3FF; border:1px solid #CFE2FF; border-radius:22px; padding:28px; margin:32px 0 42px; } .esc-callout h3{font-size:26px;line-height:1.2;margin:0 0 10px} .esc-callout p{font-size:18px;line-height:1.65;margin:0 0 12px} /* Buttons */ .esc-btnrow{ display:flex; gap:12px; width:100%; margin-top:14px; } .esc-btn{ flex:1 1 0; display:inline-flex; align-items:center; justify-content:center; padding:14px 16px; border-radius:14px; text-decoration:none; font-weight:700; color:#fff !important; background:#1F3B76; white-space:nowrap; box-sizing:border-box; } .esc-btn.secondary{background:#0F2E63} /* Headings */ .esc-h2{font-size:32px;line-height:1.2;margin:38px 0 14px} /* CTA block */ .esc-cta{ background:#EAF3FF; border:1px solid #CFE2FF; border-radius:22px; padding:36px; margin:44px 0; } .esc-cta h3{font-size:30px;line-height:1.2;margin:0 0 10px;color:#0F2E63} .esc-cta p{font-size:18px;line-height:1.6;margin:0 0 12px;color:#111} /* Mobile */ @media (max-width:860px){ .esc-btnrow{flex-direction:column} .esc-btn{width:100%} }

Medical Device Compliance & Certification Summit – Why It Matters?

Medical device and diagnostic compliance expectations are shifting earlier in the product lifecycle. IEC 60601 and related standards are no longer something teams can “handle at test.” Regulators increasingly expect standards interpretation, risk decisions, and test strategy to be visible and justified during design reviews and technical documentation development.

This shift is showing up in real ways – deeper design reviews, tougher pre-submission questions, and increased scrutiny of how standards were applied, not just whether a final test report exists.

Operating room with C-arm imaging system and surgical robot – medical device compliance context

To address this reality, Eisner Safety Consultants (ESC) is working with Nemko to deliver a three-day, in-person Medical Device Compliance & Certification Summit focused on how standards, testing, and regulator expectations intersect in real programs.

A focused, three-day program for engineering, regulatory, and compliance teams navigating IEC 60601, IEC 61010, EMC and RF requirements, certification strategy, and regulator guidance documents across FDA, EU, and other markets.

In-Person Training & Live Workshops

February 2–4, 2026
Carlsbad Inn Beach Resort, 3075 Carlsbad Blvd, Carlsbad, CA 92008

Designed for teams preparing new medical devices or diagnostics for market, working through recurring EMC or RF failures, or tightening FDA or EU MDR technical documentation ahead of submission or surveillance review.

Registration Summit Details

Who this summit is designed for

  • Electrical, EMC, RF, and systems engineers
  • Regulatory affairs and quality professionals
  • Product and compliance managers
  • Medical device and diagnostic startups preparing first submissions
  • Teams facing test failures, redesigns, or certification delays

What attendees will learn

  • How regulators evaluate standards application, not just test outcomes
  • Future impacts of IEC 60601-1, 4th edition concepts on design controls
  • Essential Performance and its role in risk management and review discussions
  • How EMC and RF strategies influence certification timelines
  • When IEC 61010 applies to diagnostic and laboratory equipment
  • Cybersecurity expectations under FDA and EU MDR
  • How guidance documents shape FDA and EU technical file expectations

How Eisner Safety Consultants Can Help

As regulatory expectations increase, delays are often caused by unclear standards interpretation, weak traceability between design decisions and requirements, and technical documentation that does not explain why choices were made.

Eisner Safety Consultants works with medical device, diagnostics, and combination device manufacturers every day to translate IEC 60601, IEC 61010, and related standards into practical design inputs, defensible test strategies, and documentation that aligns with FDA, EU, and other regulator guidance documents.

Registration Summit Details

]]> From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast https://eisnersafety.com/2025/10/19/from-engineer-to-the-iec-60601-guy-project-medtech-podcast/?utm_source=rss&utm_medium=rss&utm_campaign=from-engineer-to-the-iec-60601-guy-project-medtech-podcast Sun, 19 Oct 2025 00:04:30 +0000 https://eisnersafety.com/?p=8354
Podcast Feature

From engineer to “The IEC 60601 Guy” — my story and practical tips

I 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.

Episode 235

Project Medtech Podcast Episode 235 – Leo Eisner
Listen on Web Open Spotify

A quick personal note

Nobody starts at the top as “The IEC 60601 Guy.” 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 — stay curious, do the work, and show the work. That’s how we turn a dense standard into a practical plan.

Key takeaways from the episode

On the Project Medtech Podcast with Duane Mancini, M. Sc., I shared my genesis story of how I became known as The “IEC 60601 Guy”. Duane asked me to give listeners a 101 course on the IEC 60601 series, and I explained how I strive to “de-Greek” or demystify the standard series, and gave a preview of the big shifts coming in 4th Edition.

The “big picture” structure of the general standard, collateral standards, and particular standards

How lifecycle standards (risk management, usability, software) compare to type test standards in the 60601 family

Tangible changes to watch in the upcoming 4th Edition: clearer alarm requirements and impacts on design, QMS, & documentation

Why leaning on experts (internal or external) is key to getting this right for the impacts of 4th Edition

My goal is to “de-Greek” the process and show that IEC 60601 can be a roadmap 🗺, not a riddle

Whether you’re new to standards or a seasoned MedTech veteran, this episode shows how to approach IEC 60601 as a roadmap you can follow, instead of a riddle you can never quite solve.

What peers said

“If you want to know more about IEC 60601, Leo is the resource to go to … I recommend this episode to everybody working with medical electrical equipment.”

— Beat Keller

“Great to see how you became such an expert … I hope your story inspires young professionals to invest in becoming experts themselves.”

— Ronald Boumans

“It’s amazing that you covered the difference between process and test standards — there’s still a lot of confusion out there.”

— Tibor Zechmeister

Continue the discussion on this topic on LinkedIn

How We Can Help

If your team needs help with the IEC 60601 Series, or mapping the 4th Edition into your design controls, QMS, labeling, or testing strategy, my team at Eisner Safety Consultants and I are ready to support you.

Schedule a call with me, Leo, the IEC 601 Guy

]]> IEC 60601-1, 4th Edition Survival Guide – Why It Matters For MedTech https://eisnersafety.com/2025/09/30/iec-60601-1-4th-edition-survival-guide-why-it-matters-for-medtech/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-4th-edition-survival-guide-why-it-matters-for-medtech Tue, 30 Sep 2025 09:23:00 +0000 https://eisnersafety.com/?p=8326

IEC 60601-1, 4th Edition Survival Guide – Why It Matters For MedTech

The 4th Edition of IEC 60601-1 is no longer a future concern. Eleven of the twelve hazard fragments (WGs 37–48) have circulated Committee Drafts (CDs). All fragments have issued first CDs (WG 47 is at CD2), except WG 45 (Optical Radiation Hazards).

That means manufacturers, design houses, trade associations, test houses, and regulators must follow the working group outputs closely. If you cannot stay directly engaged in National or International (IEC) committees, you will need trusted expert guidance. These changes will impact design, QMS, labeling and IFUs, documentation, and test strategies.

One-Pager: 9 Things RA/QA Leaders Must Know

Download the One-Pager: 9 Things RA/QA Leaders Must Know

Quick to read and easy to share with RA/QA, Design, Documentation, Supply Chain, Test, and Management. Use it to brief teams and kick off transition planning for IEC 60601-1, 4th Edition.

📌 WG Status at a Glance

First-round CD comment periods are closed; the Compilation of Comments (CC) now drives edits in each WG. Expect a first wave of CD2s planned for early Dec 2025 after the Nov 2025 Milan work week, and a second wave following the Apr 2026 Shanghai meetings around Jun 2026. Stay current with CDs and CCs — or engage experts — because changes here will flow into design inputs, QMS, labeling/IFUs, V&V, and documentation.

Working Group Key Document CD Status CD Comment Period Compilation of Comments / Next Milestone
WG 37 – General requirements62A/1628/CD1st CD circulated Dec 2024closed Feb 28, 202562A/1656/CC resolve by Dec ’25; iss CD2
WG 38 – Environmental & electromagnetic environments62A/1630/CD1st CD circulated Dec 2024closed Feb 28, 202562A/1658/CC resolve by Dec ’25; iss CD2
WG 39 – User interface & alarm hazards62A/1631/CD1st CD circulated Dec 2024closed Feb 28, 202562A/1659/CC resolve by Dec ’25; iss CD2
WG 40 – Materials hazards62A/1632/CD1st CD circulated Dec 2024closed Feb 28, 202562A/1660/CC resolve by Dec ’25; iss CD2
WG 41 – Programmable electrical medical systems62A/1675/CD1st CD circulated Jun 2025closed Sep 12, 202562A/1695/CC resolve by Jun ’26; iss CD2
WG 42 – Electrical hazards62A/1676/CD1st CD circulated Jun 2025closed Sep 12, 202562A/1696/CC resolve by Jun ’26; iss CD2
WG 43 – Mechanical hazards62A/1677/CD1st CD circulated Jun 2025closed Sep 12, 202562A/1697/CC resolve by Jun ’26; iss CD2
WG 44 – Thermal & mechanical energy hazards62A/1673/CD1st CD circulated Jun 2025closed Sep 12, 202562A/1698/CC resolve by Jun ’26; iss CD2
WG 45 – Optical radiation hazards—No CD circulated yetNext: issue CD1: TBDResolve by: TBD; Next milestone: compile CC after CD1
WG 46 – Ionizing radiation hazards62A/1671/CD1st CD circulated Jun 2025closed Sep 5, 202562A/1693/CC resolve by Jun ’26; iss CD2
WG 47 – Electromagnetic exposure hazards62A/1666/CD (CD2)2nd CD circulated Jun 2025closed Aug 29, 202562A/1689/CC discuss @ next mtg 2025-11-03
WG 48 – Electromagnetic disturbances hazards62A/1672/CD1st CD circulated Jun 2025closed Sep 5, 202562A/1694/CC resolve by Jun ’26; iss CD2

9 things RA/QA leaders must know

📄 One-Pager

Sean Smith captured nine essentials from the webinar (timestamps included):

  1. Scope & Essential Performance; the boundaries for design, testing and compliance
  2. Use Environments & Users; usability files and IFUs must match
  3. Software Requirements Expanded; PEMS, SaMD, SIMD now covered
  4. Collaterals Integrated; 1,000+ pages, one-stop standard
  5. QMS Impact Areas; labeling, ISO 20417 reliance
  6. EMC & Wireless Coexistence; higher RF fields, coexistence testing
  7. Regulator Participation & Timeline; April 2030 + transition window
  8. Hardware & Documentation Updates; alarms, usability, labeling, V&V
  9. Immediate Actions; build an impact register, update labeling, begin EMC testing

The webinar replay

▶ Watch Webinar

The replay provides the why — why regulators are focusing on scope and user environments, how expanded software/PEMS requirements shift the burden of evidence, and why wireless coexistence is no longer optional outside the US.

The summary article

📝 Summary Article

This article organizes the hour-long webinar into a reference that RA/QA leaders and design managers can use to pinpoint pain points to focus on to avoid the fire drills of last-minute planning.

How to use this survival kit

  1. Kick off a cross-functional session using the one-pager as the agenda
  2. Watch replay segments together (software, EMC, labeling, etc.)
  3. Assign owners for each of the 12 hazard Working Groups across RA/QA, Design, Test
  4. Use the article as a quick reference to keep momentum
  5. Track WG outputs and rely on your internal or external experts

one-pager for overview, the replay for context, the article for detail, and the slide deck for depth give your team a GPS starting point for 4th Edition readiness.

How We Can Help

If your team needs help mapping the 4th Edition into your design controls, QMS, labeling, or testing strategy, my team at Eisner Safety Consultants and I are ready to support you.

🔗 Schedule a call with me, Leo, the IEC 601 Guy

Keep the Conversation Going

]]> 🎥 IEC 60601-1 4th Edition: Design Controls And QMS Impacts You Need To Know 📣📣 https://eisnersafety.com/2025/08/25/%f0%9f%8e%a5-iec-60601-1-4th-edition-design-controls-and-qms-impacts-you-need-to-know-%f0%9f%93%a3%f0%9f%93%a3/?utm_source=rss&utm_medium=rss&utm_campaign=%25f0%259f%258e%25a5-iec-60601-1-4th-edition-design-controls-and-qms-impacts-you-need-to-know-%25f0%259f%2593%25a3%25f0%259f%2593%25a3 Mon, 25 Aug 2025 09:31:00 +0000 https://eisnersafety.com/?p=7868

Impacts on IEC 60601-1, 4th Ed. – Webinar Recap and Industry Reactions

Insights from 110+ MedTech professionals on the upcoming 4th Edition and its impact on design controls, QMS, and labeling.

On August 15, 2025, I had the privilege of presenting the Impacts on IEC 60601-1, 4th Edition webinar as part of MLVx Friday In-Focus. The turnout was incredible, with more than 110 MedTech professionals from around the world joining. Startups, SMEs, large manufacturers, test labs, and regulators were all represented.

We unpacked the drivers and major changes in the upcoming 4th Edition, and the discussion didn’t stop when the webinar ended. Some of the most valuable insights came afterward in the LinkedIn conversations that followed.

👉 See the replay post and comments here on LinkedIn
👉 And the prior post: Major changes to IEC 60601-1, 4th Ed. are closer than you think

What the Industry Is Talking About

From the comments and follow-up conversations, four major themes stood out:

  • SME vs Large Corp Burden – Smaller companies worry the 4th Edition requirements could hit them harder than large corporations with more resources.
  • National & International Committee Involvement – Many are realizing that participating in standards development, even at the national level, gives manufacturers a seat at the table. Being involved internationally is even more powerful if you can swing it.
  • Rationale Behind Requirements – The Design Specification requires a rationale for each requirement of the standard. This is not fully addressed in Ed. 3.2, so the change should help improve industry understanding of the standard going forward.
  • Impacts on Design Controls, QMS, and Labeling – These changes are not just “paper exercises.” They will reshape how manufacturers approach design controls, QMS integration, and labeling processes across the entire product lifecycle.

Replay Video

If you missed the live session or want to revisit the details, here’s the full webinar replay:

👉 Download the slides here

Why This Matters

As the IEC 601 Guy, I’ve been deeply involved in the development of IEC 60601-1, not just for this edition but also for the previous edition. The 4th Edition is shaping up to be one of the most impactful yet, especially in how it connects to design controls, supplier oversight, and QMS processes.

Conversations like these are important because they highlight the real-world concerns of manufacturers, regulators, and test labs. They help ensure implementation of the standard is proactive, not reactive.

How We Can Help

If your team needs help mapping these 4th Edition changes into your design controls, QMS, or testing strategy, my team at Eisner Safety Consultants and I are here to support you.

🔗 Schedule a call with me, Leo, the IEC 601 Guy. My team & I are here to support your needs.

Keep the Conversation Going

Standards only evolve when industry voices are active. I encourage you to:

Together, we can make sure these changes lead to safer devices, smoother regulatory pathways, and stronger compliance strategies.

]]> Major changes to IEC 60601-1 are closer than you think https://eisnersafety.com/2025/08/15/major-changes-to-iec-60601-1-are-closer-than-you-think/?utm_source=rss&utm_medium=rss&utm_campaign=major-changes-to-iec-60601-1-are-closer-than-you-think Fri, 15 Aug 2025 18:53:33 +0000 https://eisnersafety.com/?p=7854

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.

Event Recap – MLVx Friday In-Focus

On Friday, August 15, the MLVx Friday In-Focus with Sean Smith brought together Leonard (Leo) Eisner, The IEC 60601 Guy, and 110+ professionals from around the globe, including the UK, Romania, US, France, Switzerland, Germany, Finland, and Pakistan, representing medtech manufacturers, regulators, test houses, and standards developers.

We focused on the impact of IEC 60601-1, 4th Edition, 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.

The highlight was an impromptu expert panel with leaders in risk management, software, cybersecurity, regulatory submissions, and combination devices. 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.

(Full presentation available for download at the bottom of this post.)

Unlock Your IEC 60601-1 Insider Advantage

  • Mitigate Risks: Spot disruptive changes early, prevent costly redesigns, and align documentation ahead of competitors
  • Accelerated Compliance: Seamlessly integrate evolving requirements into your development pipeline
  • Leadership Insight: The IEC 60601 Guy and our expert team track areas of interest for your organization based on draft documents
  • Behind Closed Doors: Access knowledge while it’s still being developed
  • Ready to Leap Ahead? Let’s turn this insider pipeline into your 4th Edition fast-track

📞 +1-503-709-8328
🌐 EisnerSafety.com
🔗 Schedule a Free 30-Minute Web Meeting

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

MLVx Impact of IEC 60601-1 4th Ed FINAL Vers 2025-08-15 compressed for websiteDownload

]]> Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X 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&utm_medium=rss&utm_campaign=join-me-for-an-interactive-workshop-identifying-standards-guidances-turn-standards-into-your-competitive-advantage-10x Mon, 31 Mar 2025 22:50:00 +0000 https://eisnersafety.com/?p=7796

Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the 10X Medical Device Conference in Newport Beach, Ca on May 7 – 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.

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.

I want to thank Sean Smith 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.

Need help with standards?

We provide support for your design and development process for regulatory submissions.? Eisner Safety Consultants can help by

  • Assisting with strategic compliance planning for your medical electrical product lines,
  • Providing regulatory support when FDA or a regulator asks technical questions on your submission.
  • Identification of applicable standards, laws, regulations, guidances, and directives up front to support your design process effectively.
  • Design Documentation Reviews providing expert analysis supporting the design development process to avoid unnecessary design and development delays.
  • We provide EU, US, and other countries regulatory requirement reviews of standards, laws, directives, and guidance.
  • Providing support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more.
  • Interfacing with test houses for medical safety, EMC and arrange other testing.

Feel free to schedule a web meeting with Leo or contact us.

]]> The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation 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&utm_medium=rss&utm_campaign=the-most-valuable-asset-we-each-bring-to-the-table-is%25e2%2581%2589%25ef%25b8%258f-our-unique-experiences-and-innovation Mon, 30 Sep 2024 06:46:00 +0000 https://eisnersafety.com/?p=7706

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!

Let’s connect, and explore how we can support your company with our international team of compliance & regulatory experts from Eisner Safety Consultants. 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.

Let’s meet up! 𝗕𝗼𝗼𝗸 𝘁𝗶𝗺𝗲 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁.

]]> Time and Regulators Wait for No One – Free Presentation https://eisnersafety.com/2024/09/28/time-and-regulators-wait-for-no-one-free-presentation/?utm_source=rss&utm_medium=rss&utm_campaign=time-and-regulators-wait-for-no-one-free-presentation Sat, 28 Sep 2024 13:03:00 +0000 https://eisnersafety.com/?p=7700

Free presentation in London 🇬🇧🎡🏰 — With Leo Eisner, The60601Guy, & Ian Sealey

𝗪𝗵𝗮𝘁’𝘀 𝗼𝗻 𝘁𝗵𝗲 𝗺𝗲𝗻𝘂🍰?

• Some 𝗳𝘂𝘁𝘂𝗿𝗲 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 of IEC60601-1 , 4th being considered you 𝙢𝙖𝙮 𝙣𝙤𝙩 𝙚𝙭𝙥𝙚𝙘𝙩:
Gas Pathways,
Cleaning,
Disinfection,
AI/ML,
Voice Input/Output,
Adhesives for Applied Parts,
PPE,
and so much more….

• IEC60601-1 , 4th Ed.
• Applicable Standards
• Future Proofing Test Plans

IEC 60601-1, 4th edition is currently in development and there are some SIGNIFICANT changes underway.

Ian Sealey, Michael Kipping, James Pink and I, Leonard (Leo) Eisner, The60601Guy, will be discussing the changes, indicative timescales, and how to plan for them.

𝗪𝗵𝗲𝗻, 𝘄𝗵𝗲𝗿𝗲, 𝗵𝗼𝘄:
7 𝘖𝘤𝘵𝘰𝘣𝘦𝘳 2024
𝘊𝘭𝘢𝘺𝘵𝘰𝘯 𝘏𝘰𝘵𝘦𝘭 𝘊𝘩𝘪𝘴𝘸𝘪𝘤𝘬
𝘈𝘳𝘳𝘪𝘷𝘢𝘭 𝘧𝘳𝘰𝘮 𝟱:𝟬𝟬𝙥𝙢
𝘚𝘵𝘢𝘳𝘵 𝟱:𝟯𝟬𝙥𝙢
𝘌𝘯𝘥 𝟴:𝟰𝟱𝙥𝙢
𝙉𝙚𝙩𝙬𝙤𝙧𝙠𝙞𝙣𝙜 𝙖𝙣𝙙 𝙙𝙧𝙞𝙣𝙠𝙨 🍺 afterwards

TICK TOCK ⏰ 🧨 – Time is starting to run out for signing up for this event. If you wait too long there won’t be room so sign up now before we fill up. Don’t wait tooooooo long and miss this great opportunity to learn from experts.

Register by using our Contact form, send Leo an email (go to bottom of page) or send Leo a LinkedIn message via his profile.

Join the conversation on the LinkedIn Post and leave a comment.

]]> What Standards Apply to My Device? Podcast #383 https://eisnersafety.com/2024/09/25/what-standards-apply-to-my-device-podcast-383/?utm_source=rss&utm_medium=rss&utm_campaign=what-standards-apply-to-my-device-podcast-383 Wed, 25 Sep 2024 01:00:00 +0000 https://eisnersafety.com/?p=7686

📣📣 𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru‘s very own😎🎉

𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:‼
• Why standards like IEC60601 are crucial for medical device development
• Steps for identifying proper standards for your product
• How to integrate standards into your design process
• Mistakes & consequences of ignoring standards
• Tools for staying updated on changing standards & regulations
• How startups can navigate standards with limited resources

If you have any thoughts and comments on the podcast I’d would like to hear from you 🫵 Comment on the LinkedIn post about the Podcast

If you found this interesting or helpful, consider Reposting 🔄 on LinkedIn; follow me, Leonard (Leo) Eisner, the60601Guy and click the 🔔 so you don’t miss future content.

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, & other country regulatory requirements & standards, laws, directives, and more. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. His team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here to support your needs.

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.

Feel free to schedule a web meeting with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

]]> Join Leo Eisner In The Next Let’s Talk Risk Episode https://eisnersafety.com/2024/08/30/join-leo-eisner-in-the-next-lets-talk-risk-episode/?utm_source=rss&utm_medium=rss&utm_campaign=join-leo-eisner-in-the-next-lets-talk-risk-episode Fri, 30 Aug 2024 21:34:03 +0000 https://eisnersafety.com/?p=7674

I'm excited to be joining this event with Naveen Agarwal, Ph.D. on the next Let's Talk Risk episode on Sept 6, 11:00 -11:30AM EDT our discussions I'm sure will be interesting talking about my work in the development of 4th ed of IEC 60601-1 and so much more.

Naveen likes to talk about Guest Speaker's career's and how they got to where they are. So, it is possible this topic may come up. You can see much of my career information by going to Leo Eisner's LinkedIn Profile.

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I’m excited to be joining this event with Naveen Agarwal, Ph.D. on the next Let’s Talk Risk episode on Sept 6, 11:00 -11:30AM EDT our discussions I’m sure will be interesting talking about my work in the development of 4th ed of IEC 60601-1 and so much more.

Naveen likes to talk about Guest Speaker’s career’s and how they got to where they are. So, it is possible this topic may come up. You can see much of my career information by going to Leo Eisner’s LinkedIn Profile.

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, & other country regulatory requirements & standards, laws, directives, and more. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. He team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here to support your needs.

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.

Feel free to schedule a web meeting with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

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