ISH1 – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Thu, 11 Jun 2026 05:24:31 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png ISH1 – Eisner Safety Consultants https://eisnersafety.com 32 32 Keep the Patient at the Center: My Full Week at IMSC26 (and Why Getting Ahead of IEC 60601-1, 4th Edition Is Really About People) https://eisnersafety.com/2026/06/12/keep-the-patient-at-the-center-my-full-week-at-imsc26-and-why-getting-ahead-of-iec-60601-1-4th-edition-is-really-about-people/?utm_source=rss&utm_medium=rss&utm_campaign=keep-the-patient-at-the-center-my-full-week-at-imsc26-and-why-getting-ahead-of-iec-60601-1-4th-edition-is-really-about-people Fri, 12 Jun 2026 07:00:00 +0000 https://eisnersafety.com/?p=8521 Leo Eisner presenting the impact of IEC 60601-1, 4th Edition at IMSC26
Presenting at IMSC26: getting ahead of IEC 60601-1, 4th Edition
๐Ÿ“ฌ Before you scroll: I write a newsletter for MedTech teams who do not want to be surprised by IEC 60601-1, 4th edition. Plain-language updates on the fragments, the working groups, and what each change means for design, QMS, labeling, and testing. Subscribe here and get the next update in your inbox.

This was a week of learning I will not forget, and one that reminded me why I do this work. Strip away the standard numbers, the acronyms, the requirements, and the test reports, and the whole event came back to a core concept: keep the patient at the center and keep them safe. That is the thread I want to pull through this longer recap, the one that did not fit in a single LinkedIn post.

A quick note on format. On LinkedIn I kept this tight. Here on the blog I have room to go deeper, so this version adds more on the structure of 4th edition, more on how I think about the Conformity Evaluation Plan and File, and a closing section on what I am personally carrying back to the standards committees. If you only have two minutes, the LinkedIn version covers the highlights. If you want the real detail, you are in the right place.

Why I keep saying “get ahead of 4th edition”

Let me set the stage, because it is the backbone of almost everything I presented this week. IEC 60601-1, 4th edition is not a distant, someday concern. It is being actively drafted right now, fragment by fragment, across a set of working groups (broadly WG 37 through WG 48), and all of those fragments have already circulated Committee Drafts (CD1s, and some have done CD2s). The collateral standards many of us have treated as separate documents are being folded into the core of 60601-1. The structure is moving toward clearer, more “atomic” requirements, each one distinct and design-ready, with rationale attached and tighter alignment to the IMDRF Essential Principles. The scope is broadening to span lay users and professional users, home and EMS and professional environments, and patients of every age, human and animal.

Here is why that matters to you, not just to standards people like me. When this edition lands, the gap between a product designed against 3rd edition assumptions and one designed with 4th edition in mind will show up as redesign, retesting, and documentation rework. That is the expensive way to meet a standard. The inexpensive way is to read the direction of travel now and bake it into your design inputs, your risk management file, your labeling, and your test strategy while you still have design freedom. That is the whole argument in one breath: plan now, avoid the fire drills later.

It started Monday in Boxborough: TรœV Rheinland and IEC 60601-1, 4th Edition

The week kicked off in Boxborough, Massachusetts, with TรœV Rheinland North America’s first IEC 60601-1, 4th Edition seminar, held at their Northeast Technology and Innovation Center. I shared the stage with Caitlin Brady and Elizabeth Casey, and for the Q&A we pulled in two additional local experts from our Working Groups, Ashleigh McNaboe and Jenna Smolko-Jaser. Dr. Nicholas T. Kirkland kindly introduced me that morning and even worked my Star Trek podcast into the introduction, which set a warm and slightly playful tone for a deep technical day. You can listen to the podcast here.

That left me as the only man on the panel, standing alongside four exceptional women in STEM, and I could not have been prouder to be there. These are not token seats. On the standards committees I work with, women like these are among the strongest, most technically capable people in the room, the ones I lean on and learn from. Our field is finally heading in the right direction on this, and it needs to keep going. When I started more than 40 years ago, engineering and the technical fields were a hard place for women. It is better now, I see real progress even in my son’s college, though equity is still a work in progress. Panels and committees stacked with talent like this are how we close the gap, and being outnumbered by minds that sharp is an honor every single time.

If you could not join live, the recording and the slide deck are available here.

Leo Eisner and Caitlin Brady at TรœV Rheinland
Leo & Caitlin after the seminar, hanging with the TรœV guy

A deeper look at the CEF and CEP, and why “Bridge, not wait”

At IMSC26 I ran a 4-hour workshop, “Building and Using an IEC 60601 Conformity Evaluation File for Today and Tomorrow,” with a group of about 20. Without reproducing the workshop materials, here is the thinking, because it is useful even if you were not in the room.

The problem the CEF and CEP solve is fragmentation. Today, evidence tends to live in silos: test reports here, design reviews there, the risk management file somewhere else, the usability engineering file in its own world. Different formats, different levels of detail, and a reviewer at a test lab or Notified Body who has to hunt to piece it together. A Conformity Evaluation Plan flips that. You plan, up front, how each applicable requirement will be evaluated, then the Conformity Evaluation File becomes the executed plan with the evidence attached and traceable from requirement to hazard to test method to acceptance criteria to result. It is the difference between a complete file and a usable one, a distinction that came up in other sessions this week as well.

The line I kept coming back to was “Bridge, not wait.” 3rd edition does not require a formal CEP, but nothing stops you from adopting the mindset now. Teams that build this muscle today will transition into 4th edition smoothly, and they will hand reviewers a cleaner package in the meantime. If you want the practical version of this for your own projects, that is exactly the kind of thing I help clients set up, and the kind of thing I write about in the newsletter.

๐Ÿ“ฌ Quick break: If this level of detail is useful, it is a sample of what I send out. Subscribe to the newsletter for plain-language 4th edition updates and practical compliance tips you can actually use.

I also delivered a 45-minute session, “The Impact of IEC 60601-1, 4th Edition on RA/QA, Design, Document Control, Test, Supply Chain, and Management,” to a room of close to 100 with more online, and even a few of my own clients in the seats. The point of that talk was to take the drivers behind the next edition and trace them into the real work across functions, because a standard change is never just an engineering change. It ripples into your QMS procedures, your document control, your supplier and test planning, and your management reviews.

A quick note on why this is my lane: I co-convene IEC/TC 62/SC 62A/WG 39 (user interface for IEC 60601-1, 4th edition), am a member of IEC/TC 62/SC 62A/WG 37 (general requirements) and IEC/TC 62/SC 62A/AG 50 (the editing team leading the 4th edition of IEC 60601-1), serve as US co-chair of AAMI TAG 62D on electromedical equipment, and sit on ISO/TC 210/WG 2. A lot of what I shared comes straight from inside the rooms where this edition is being written.

It also meant a lot to hear Jean-Yves Pairet, Quality Assurance Director at CLEIO, write that the workshop “made a clear case for preparing for IEC 60601-1 4th edition now, rather than waiting four years for it to roll out,” and that he left “with a practical, immediately usable approach CLEIO can already apply to current projects.” Practical and immediately usable is exactly what I am going for.

Jean-Yves Pairet and Leo Eisner
Jean-Yves & Leo during the CEF / CEP workshop, taking a short break

The talks that stuck with me

Michelle Tarver, MD, PhD, Director of FDA’s CDRH, delivered a keynote that was simply outstanding, with patient safety running clearly through the entire keynote. She covered the Case for Quality programs (the Voluntary Improvement Program and the Achieving Quality Excellence Collaborative Community), the Accreditation Scheme for Conformity Assessment (ASCA), supply chain resilience including the very real PFAS challenge, and QMSR, now in effect and incorporating ISO 13485:2016. The common thread, and the reason it ties to my own message, is that every one of those rewards teams who prepare early instead of scrambling at a deadline.

Michelle Tarver giving the CDRH keynote
Michelle Tarver giving the keynote presentation

James Pink gave a talk I, and many of us, will be thinking about for a long time: “When You Become the Patient: A Safety Professional on the Other Side of the Decision.” He laid out what the formal risk model does well (sets the safety assessment scope, identifies hazards and hazardous situations, defines controls and acceptable residual risk, supports surveillance and signal detection) and what lies outside its boundary: cross-device effects over time, the psychological burden between appointments, the cumulative impact of “acceptable” events, and the lived experience across encounters.

His concept of “bound risk” has stuck with me. The manufacturer owns the chain up to the device-level event, but the path from a hazardous situation to actual patient harm gets distributed to the health institutions that control the diagnostic and therapeutic pathway. His example: an MRI down in a radiology suite. Nobody is crushed or burned, the file says no harm, and meanwhile patients sit stalled on the diagnostic pathway with a clock ticking inside them. That is harm. It just is not the kind our current files capture. He also made the uncomfortable point that adverse events are among the weakest signals we will ever get, because the system often needs someone to be seriously injured before anyone investigates properly.

James and I have known each other for about five years and have worked through plenty of medical device and IEC 60601-1 questions together, so this one lands close to home. During the Q&A I told him I would be thrilled to have him speak to the IEC TC 62, SC 62A, and the 4th Edition IEC 60601-1 teams writing the standard. Here is why. We still do not focus enough on the patient. We focus on the engineering and the technology, and those matter, but technology and standards are only one piece of the puzzle. The patient pathway is just as critical, and arguably more. A device can pass every clause we write and still leave a patient stalled, anxious, and unsafe somewhere along their journey. The people writing the standards need to hear this clearly, and hearing it from someone directly impacted who also understands the risk management perspective drives the point home far better than I could on my own.

James Pink presenting his keynote
James Pink presenting the keynote (the “formal model and where it ends” boundary slide)

Susan Neadle presented on “Streamlined” Risk Management for Drug-Device Combination Products, touching on the draft Technical Specification ISO TS 24971-3 (guidance on applying ISO 14971 to combination products) and the integration path with AAMI TIR 105. The problem she names is one anyone working at the intersection of device, drug, and user knows in their bones: multiple frameworks (ISO 14971 for the device, ICH Q9(R1) for the drug) overlap, execution is siloed, and the result is inconsistent terminology, traceability gaps, and interaction risks that go under-assessed, especially the drug-device interactions and the way a user actually handles the combined system. Streamlined does not mean lighter. It means connected, consistent, and decision-driving. David Cronin of Cognition followed with a strong session on minimizing patient risk at the intersection of drug and device risks. Meeting David in person was a real highlight. He carries deep knowledge across medtech, pharma, and combination products, and he and Susan go way back, which showed in how naturally their two talks complemented each other.

Susan Neadle and Leo Eisner
Susan Neadle & Leo Eisner after our back to back presentations

A personal highlight: Susan and I were initially scheduled at the same time, and she asked Bijan to reschedule so she could watch my presentation. That kind of attention to detail from Bijan is part of what makes this conference special, and it honestly blew me away. I have had huge respect for Susan for many years as the combination products expert, and she knows me, as many do, as the IEC 60601 Guy. There is a lot of mutual respect in this conference and a huge amount of knowledge and decades of experience to tap into.

Friday panels: what do we really mean by “risk,” and how mature is it?

Friday brought panels, a new addition this year, and they delivered. One of the liveliest was “What Do We Really Mean by ‘Risk’? US vs EU Perspectives,” a genuinely useful debate about how the same word carries different weight on different sides of the Atlantic. It sounds academic until it shows up in your submission strategy and your acceptable-risk arguments.

Fubin Wu’s panel introduced his Risk Management Maturity Model (RM3), and I am very glad I sat through it. It is a first-principles effort to answer a question we rarely measure well: what does good, and great, risk management actually look like, and how do you grow toward it? The panel brought together FDA voices including co-chairs Keisha Thomas and Melissa Burns alongside industry core-team members. As Fubin puts it, RM3 pushes past “did we follow the process?” to a deeper question: “are we making decisions with confidence that fulfill the intent of the process to serve patients?” With QMSR now in force, that shift from better documentation to better decision-making is the real work.

AI, human factors, and more sessions worth your time

My associates at Prodct Studio, Christie Johnson and Devon C. Campbell, ran a fantastic Tuesday workshop, “The AI-Powered MedTech Professional.” They also know how to host. I may have “dragged” a few TรœV Rheinland friends to their Monday-night party. Great hosts, every time.

I did not catch all of Shannon Hoste’s usability sessions, and I wanted to. Her work asks a question our whole field needs to sit with: are human factors processes ready for AI in medical devices? The risks she maps (automation bias, loss of situational awareness, and function allocation between human and AI) are real use-related hazards, and the comfortable assumptions, like “the clinician will catch it,” do not hold up. Her two-part HFE workshop with Jonathan Kendler, on factoring human factors data into your risk file and safety case, is exactly the kind of practical, on-the-ground content I look for.

One session I did sit through and keep thinking about was Steve Gompertz and Jean Blom’s “Hidden Influences: How Risk Management Can Go Wrong.” It gave us a phrase worth posting in every quality department: “dysfunctional compliance,” where the process is followed precisely but the results still are not acceptable, because the focus drifts to how the work gets done instead of the value it is meant to produce. Risk management is done by humans, and the human factors of decision-making belong inside our risk process.

The fun version: standards are star maps

If you want the more playful version of the philosophy underneath all of this, enjoy The โญ• Podcast episode where I joined Faisal Kamal, “The Star Map to the Future.” The core idea: IEC 60601 is not a rulebook, it is a star map built from decades of engineering mistakes, test data, regulatory learning, and field experience. We even used the Star Trek tricorder as an analogy for the electronic devices now used in homes and EMS environments, the noisy, unpredictable, RF-filled spaces that 4th edition deliberately pushes us to design for. There is also a companion write-up, What’s NASA & Star Trek have to do with IEC 60601?

From NASA to IEC 60601, A Lifelong Trek for Safer Devices
From NASA to IEC 60601: A Lifelong Trek for Safer Devices

What I am carrying back to the committees

Conferences like this are not just about what you present, they are about what you take home to the work. Three things are coming back with me into the standards rooms. First, the patient pathway belongs in our thinking, not just the device-level event, and James Pink made that case better than anyone. Second, maturity matters more than compliance, and RM3 gives us a vocabulary for it. Third, the human side of risk, the biases and blind spots Gompertz and Blom mapped, deserves a seat at the table inside our risk process, not as an afterthought. If we hold those three together while we write 4th edition, we end up with a standard that protects real people in real environments, which is the entire point.

Resources to get ahead of IEC 60601-1, 4th Edition

If this left you wanting a head start, here is where I would point you first:

The part that matters most

The theme of the whole week was patient safety and risk management, but the human side stuck with me just as much. I finally met people in person whom I have worked with for years, in some cases for decades. Voices and email signatures became handshakes and hugs. That never gets old. I had great conversations with Fubin Wu and David Bonnett on the risk maturity work, time with Susan Neadle, James Pink, David Cronin, Steve Gompertz, and Jean Blom, and real face time with Bijan Elahi himself. There were genuinely too many good people to name them all here, and that is a wonderful problem to have. A small backstory I am proud of: Caitlin Brady and Elizabeth Casey of TรœV Rheinland were at IMSC26 because I suggested they sponsor, and they grabbed the very last sponsor spot. Sometimes a nudge at the right moment is all it takes.

A heartfelt thank you to Bijan Elahi, Jamie D. Selby and the entire volunteer team, to my TรœV Rheinland North America colleagues, and to Christie Johnson, Devon C. Campbell, and the Prodct Studio crew. IMSC alternates between the US and Europe so attendees on both sides of the Atlantic get a fair shot, and IMSC27 heads to Europe, with Ireland, Belgium, and Portugal in serious consideration.

Onward. And if you are writing standards or developing products, keep the patient at the center.

Live long and prosper, and keep your patients safe, in every environment, be it on earth ๐ŸŒŽ or in space ๐Ÿ›ฐ, on every device. To infinity and beyond, we can design for patient safety, in all its forms, if we really set our minds to it, with such a dedicated set of great minds as this group. ๐Ÿ––๐Ÿš€

๐Ÿ“ฌ Do not let the next 4th edition update pass you by.

I send practical, plain-language guidance on IEC 60601-1, 4th edition and the broader 60601 and 61010 world, written for the people who actually have to design, test, document, and certify these products. No fluff, just what helps you get ahead of the curve.

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Schedule a call with Leo Learn more about our work

Leonard “Leo” Eisner ยท The IEC 60601 Guy ยท Eisner Safety Consultants

]]> Medical Device Compliance & Certification Summit โ€“ 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 โ€“ 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 โ€œhandle at test.โ€ 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 โ€“ 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 โ€“ 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 2โ€“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 โ€œThe IEC 60601 Guyโ€ – 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 โ€œThe IEC 60601 Guyโ€ โ€” 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 โ€“ Leo Eisner
Listen on Web Open Spotify

A quick personal note

Nobody starts at the top as โ€œThe IEC 60601 Guy.โ€ 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 โ€” stay curious, do the work, and show the work. Thatโ€™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 โ€œIEC 60601 Guyโ€. Duane asked me to give listeners a 101 course on the IEC 60601 series, and I explained how I strive to โ€œde-Greekโ€ or demystify the standard series, and gave a preview of the big shifts coming in 4th Edition.

The โ€œbig pictureโ€ 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 โ€œde-Greekโ€ the process and show that IEC 60601 can be a roadmap ๐Ÿ—บ, not a riddle

Whether youโ€™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

โ€œIf you want to know more about IEC 60601, Leo is the resource to go to โ€ฆ I recommend this episode to everybody working with medical electrical equipment.โ€

โ€” Beat Keller

โ€œGreat to see how you became such an expert โ€ฆ I hope your story inspires young professionals to invest in becoming experts themselves.โ€

โ€” Ronald Boumans

โ€œItโ€™s amazing that you covered the difference between process and test standards โ€” thereโ€™s still a lot of confusion out there.โ€

โ€” 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

]]> ๐ŸŽฉ Get your reviewerโ€™s hat on – IEC 60601-1, 4th Edition Draft Fragments Have Droppedโ€ผ๏ธ ๐Ÿš€ https://eisnersafety.com/2025/06/28/%f0%9f%8e%a9-get-your-reviewers-hat-on-iec-60601-1-4th-edition-draft-fragments-have-dropped%e2%80%bc%ef%b8%8f-%f0%9f%9a%80/?utm_source=rss&utm_medium=rss&utm_campaign=%25f0%259f%258e%25a9-get-your-reviewers-hat-on-iec-60601-1-4th-edition-draft-fragments-have-dropped%25e2%2580%25bc%25ef%25b8%258f-%25f0%259f%259a%2580 Sat, 28 Jun 2025 01:09:39 +0000 https://eisnersafety.com/?p=7826


Posted on LinkedIn June 19, 2025. Updated with extra blog content June 25, 2025.

Over the last two weeks โ€“ and with a Friday night (6/20/25 Geneva time – late) finale still to come โ€“ weโ€™ve seen CD1s and CD2 (WG 47 ONLY) fly out for Fragments 5, 6, 7, 8, 10, 11, and 12 from WG 41 through WG 48, but for WG 45.

This is not just standards spring cleaning – these are foundational changes to the IEC 60601-1 General Standard, folding the Collateral standards into the core. If you have medical electrical equipment, medical electrical systems or software SaMD or SiMD you need to be aware of these changes. If youโ€™re a manufacturer, test lab, trade association, Notified Body, Regulator or other interested party who owns a risk fileโ€ฆ you need to review this.

These fragments cover hazards related to: โ€ข Electrical, mechanical, thermal, and fire โ€ข Software & PEMS (SaMD, SiMD, firmware, OSโ€ฆ) โ€ข EM Disturbance, wireless coexistence, ionizing radiation, and electromagnetic exposure (EMF)

๐Ÿ• The International comment deadlines start closing August 29th, with more due by September 12th. National deadlines close much sooner (does your summer holiday schedule conflict?๐Ÿน๐Ÿ)

๐Ÿ“Ž Donโ€™t wait for the FDIS โ€“ get involved now or get caught off guard later.


๐Ÿ‘‰ Read the full breakdown of all Working Groups, due dates, and what you should do now:

Hereโ€™s the whoโ€™s who of the Working Groups behind the fragments with CD1 to issue 20 July:

โ€ข WG 41 โ€“ PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards ๐Ÿ”— WG 41 link

โ€ข WG 42 โ€“ Electrical hazards ๐Ÿ”— WG 42 link

โ€ข WG 43 โ€“ Mechanical hazards ๐Ÿ”— WG 43 link

โ€ข WG 44 โ€“ Thermal and fire hazards ๐Ÿ”— WG 44 link

Other Fragments CD1s & CD2 have recently published – clock ticking ๐Ÿ•ฐ to get your comments in:

โ€ข Fragment 11 โ€“ WG 47: Electromagnetic exposure hazards (not optical or ionizing but including SAR) ๐Ÿ”— WG 47 link CD2, closes 29 August

โ€ข Fragment 10 โ€“ WG 46: Ionizing radiation hazards ๐Ÿ”— WG 46 link CD1, closes 5 September

โ€ข Fragment 12 โ€“ WG 48: Electromagnetic disturbances (including wireless coexistence) ๐Ÿ”— WG 48 link CD1, closes 5 September

The early pack of CD1 Fragments released late last year

Fragments 1โ€“4 and 11 from WG 37โ€“40 & WG 47 were released as CD1 back on December 6, 2024, with comments closing February 28, 2025. You can still access them if youโ€™re a National Committee member for SC62A or a WG participant. If not, consider joining โ€” this is a major transformation, and early awareness = better preparation. ๐Ÿ”— Access link

Here’s a handy summary table of the IEC 60601 Fragments, their WG #s, their titles, the issue & close dates & more.

Who Should Be Reviewing

  • Design and Systems engineers
  • Risk management experts/leaders
  • Electrical & mechanical designers
  • Software designers (SaMD/SiMD, firmware, OS)
  • EMC/EMF compliance leads
  • Compliance engineers
  • Regulatory and quality teams
  • Usability & human factors engineers
  • Test labs
  • Trade Associations
  • Regulators
  • Notified Bodies
  • Other Interested Parties

โœ… What You Need to Do

  1. Review the Drafts & the 4th ed. Design & Architecture Specs Now โ€ข Assign key experts by hazard/WG โ€ข Map against your design controls: Design Spec โ€ข Understand the architecture spec: Architecture Spec
  2. Track IEV Part 880 Terms โ€ข Stay aligned with the evolving definitions: Terms & Definitions
  3. Analyze Impact to Products โ€ข Run gap assessments โ€ข Identify implications for design, testing, and documentation
  4. Submit Comments โ€ข Through your National Committees (ANSI, BSI, DIN, etc.) โ€ข Clear, technically sound feedback = meaningful influence
  5. Update Design & Risk Inputs โ€ข Donโ€™t wait for the final version to start aligning
  6. Integrate Into Product Roadmaps โ€ข Work with R&D, QA/RA, and exec sponsors โ€ข Flag projects needing early adaptation
  7. Engage the Right Experts โ€ข Join WGs or partner with someone whoโ€™s inside (๐Ÿ‘‹) โ€ข Stay active โ€“ your input now shapes what becomes final
  8. Invest in Training โ€ข Get smart now to avoid surprises later

๐Ÿ“Ž Donโ€™t wait for the FDIS โ€“ get involved now or get caught off guard later.

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.

]]> 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 isโ‰๏ธ 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 ๐Ÿ‡ฌ๐Ÿ‡ง๐ŸŽก๐Ÿฐ 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, ๐—ฏ๐—ผ๐—ผ๐—ธ ๐—ป๐—ผ๐˜„ ๐—ผ๐—ป ๐—บ๐˜† ๐˜€๐—ฝ๐—ฒ๐—ฐ๐—ถ๐—ฎ๐—น ๐—ฐ๐—ฎ๐—น๐—ฒ๐—ป๐—ฑ๐—ฎ๐—ฟ for ๐—บ๐˜† ๐—Ÿ๐—ผ๐—ป๐—ฑ๐—ผ๐—ป ๐˜ƒ๐—ถ๐˜€๐—ถ๐˜. Iโ€™d love to chat!

Letโ€™s connect, and explore how we can support your company with our international team of compliance & regulatory experts from Eisner Safety Consultants. Iโ€™m eager to learn what youโ€™re working on and how youโ€™re driving change and innovation in the industry, and how we can support you to get you to market faster.

Letโ€™s meet up! ๐—•๐—ผ๐—ผ๐—ธ ๐˜๐—ถ๐—บ๐—ฒ ๐—ผ๐—ป ๐—บ๐˜† ๐˜€๐—ฝ๐—ฒ๐—ฐ๐—ถ๐—ฎ๐—น ๐—ฐ๐—ฎ๐—น๐—ฒ๐—ป๐—ฑ๐—ฎ๐—ฟ for ๐—บ๐˜† ๐—Ÿ๐—ผ๐—ป๐—ฑ๐—ผ๐—ป ๐˜ƒ๐—ถ๐˜€๐—ถ๐˜.

]]> How to ID Applicable Standards – Combinate Podcast https://eisnersafety.com/2024/08/07/how-to-id-applicable-standards-combinate-podcast/?utm_source=rss&utm_medium=rss&utm_campaign=how-to-id-applicable-standards-combinate-podcast Wed, 07 Aug 2024 21:08:23 +0000 https://eisnersafety.com/?p=7632  

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 https://bit.ly/LIPostCombinatePodcast148LeoEisner

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

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

Join us ๐Ÿซต in the conversation on LinkedIn and leave your comments so we can continue this discussion.

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 is an expert on standards development and sits on many standards committees. 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.

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 call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

]]> Watch Free Webinar IEC 60601 Amendments & CB Scheme https://eisnersafety.com/2024/06/28/watch-free-webinar-iec-60601-amendments-cb-scheme/?utm_source=rss&utm_medium=rss&utm_campaign=watch-free-webinar-iec-60601-amendments-cb-scheme Fri, 28 Jun 2024 07:18:13 +0000 https://eisnersafety.com/?p=7606

Learn from an ๐—ถ๐—ป๐˜€๐—ถ๐—ฑ๐—ฒ๐—ฟ ๐—ฐ๐—ผ๐—บ๐—บ๐—ถ๐˜๐˜๐—ฒ๐—ฒ ๐—บ๐—ฒ๐—บ๐—ฏ๐—ฒ๐—ฟ that wrote portions of ๐—œ๐—˜๐—– ๐Ÿฒ๐Ÿฌ๐Ÿฒ๐Ÿฌ๐Ÿญ-๐Ÿญ, ๐—ฒ๐—ฑ ๐Ÿฏ.๐Ÿฎ ๐—”๐—บ๐—ฒ๐—ป๐—ฑ๐—บ๐—ฒ๐—ป๐˜๐˜€ and is involved in the development of the Fourth Edition of IEC 60601-1. If you want to learn about these updates to the standard and the IEC 60601 Amendments Project – You’re in luck – Leonard (Leo) Eisner the “๐—œ๐—˜๐—– ๐Ÿฒ๐Ÿฌ๐Ÿฒ๐Ÿฌ๐Ÿญ ๐—š๐˜‚๐˜†” from Eisner Safety Consultants partnered with Holly Rossington of BSI to present the webinar “Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers”

We answered some of the most pressing questions, such as:
โ€ข How North American medical device manufacturers can leverage the CB scheme and its benefits.
โ€ข Examples of medical devices BSI can certify.
โ€ข Key changes introduced in the latest edition of IEC 60601-1 (Ed. 3.2):
o Clause 7, Identification and marking.
o Clause 8, Protection against electrical hazards.
o Clause 13, Hazardous situations and fault conditions.
And lots more.

Watch to the end to get other valuable resources too!!! ๐Ÿ’ฅ๐ŸŽ‰๐Ÿฅณ๐Ÿ‘โœˆ

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic 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 is an expert on standards development and sits on many standards committees. 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.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free toย schedule a meeting Leoย or contact Leo atย Leo@EisnerSafety.comย or through ourย contact form.

]]> Leo Eisner the “IEC 60601 Guy” co-presenter in BSI Webinar https://eisnersafety.com/2024/05/30/leo-eisner-the-iec-60601-guy-co-presenter-in-bsi-webinar/?utm_source=rss&utm_medium=rss&utm_campaign=leo-eisner-the-iec-60601-guy-co-presenter-in-bsi-webinar Thu, 30 May 2024 18:54:07 +0000 https://eisnersafety.com/?p=7559

Webinar: Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers

When: Tuesday, June 25, 2024  

Time: 11:00 a.m. – 12:00 p.m. EDT 

About the Event: Join BSI & Leo Eisner for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Leo the “IEC 60601-1 Guy” will present the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.

Sign up for this webinar

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic 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 is an expert on standards development and sits on many standards committees. 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.

We work with many test labs for Medical Electrical 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 call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

]]> IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization https://eisnersafety.com/2024/05/06/iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization Mon, 06 May 2024 04:46:53 +0000 https://eisnersafety.com/?p=7532

Last week, 29 Apr โ€“ 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

The focus of this meeting was โ€œlevel settingโ€ all the parties on the development of requirements for the 4th edition of IEC 60601-1, which sets safety requirements for medical electrical equipment (also known as active medical devices). Twelve working groups (WGs) gathered to strategize their efforts, guided by the Design Specification for the 4th edition and the Architecture Specification.  The first day was set with training to help all parties get an understanding of project requirements and ask questions based on the Design Specification and the Architecture Specification. The next 3 days focused on the 12 WGs working on their strategies for the start of the project and the plans to move forward. The last day was a wrap-up and getting feedback on how to improve the process with lots of great discussion from the week. 

An Advisory Group (AG 50) is used to collaborate with all 12 WG co-convenors and secretaries, and IEC SC 62A officers ensuring the overall success of the project.

As a co-convenor for WG39, which addresses User Interfaces (Including information provided by the manufacturer, Alarm Systems and Usability Engineering Process), I am honored to be part of this excursion in the development of this standard for the support of the healthcare industry for the next edition. Alongside my co-convener, Martin Stangenberg, we led discussions and consensus-building within our WG. Our WG is comprised of amazing experts.ย  We had over 30 experts in the room including regulators from 5 countries; test houses; usability, labeling, alarm systems, and robotics experts. We had over half of our experts from the whole WG in attendance at the meeting. Our responsibilities include coordinating with other experts to develop basic safety and essential performance requirements related to User Interface Aspects Hazards for our part of the standard. Each WG is working on a different set of hazards as described in the post “IEC 60601-1, 4th ed. — Where do we stand?“.

WG 39 Group Photo

As an expert on WG37, I also spent part of the week with WG 37 developing requirements related to general issues concerning underlying concepts including basic safety & essential performance, single fault safety, type testing.  Correlation with processes relevant for IEC 60601-1 defined by other process standards (e.g., risk management) for IEC 60601-1, 4th ed.

It was great to meet all the new people and see them get involved for the first time in the standardization process as well as work with familiar faces I have worked with for many years. It is a well-rounded group of individuals, supporting this next edition, with many different perspectives but with the mindset to provide the patient with a safe product.

Closing Meeting

I extend my appreciation to all who have made this happen — the officers, the design specification and architecture specification teams (a long road to get here), my mentors, and all the national committee experts for coming together in this massive effort. Now the real work of the experts in the WGs beginsโ€ฆ.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic 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 is an expert on standards development and sits on many standards committees. 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.

We work with many test labs for Medical Electrical 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 call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

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