Podcast – Eisner Safety Consultants

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)

leoeisner — Fri, 12 Jun 2026 07:00:00 +0000

Presenting at IMSC26: getting ahead of IEC 60601-1, 4th Edition

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: TÜV Rheinland and IEC 60601-1, 4th Edition

The week kicked off in Boxborough, Massachusetts, with TÜV 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 & Caitlin after the seminar, hanging with the TÜV 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.

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 & 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 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 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 & 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 TÜV 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 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

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:

IEC 60601, 4th Edition: What’s Changing and How to Prepare — my strategic-shifts overview and companion to the Easy Medical Device podcast episode.
IEC 60601-1, 4th Edition Survival Guide: Why It Matters for MedTech
IEC 60601-1, 4th Edition: Design Controls and QMS Impacts You Need to Know
Get Your Reviewer’s Hat On: 4th Edition Draft Fragments Have Dropped
From Engineer to “The IEC 60601 Guy” (Project Medtech Podcast)

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 TÜV 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 TÜV 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 or in space , 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.

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

IEC 60601, 4th Edition: What’s Changing and How to Prepare

leoeisner — Sat, 28 Feb 2026 21:33:00 +0000

IEC 60601-1, 4th Edition

Strategic Shifts and How to Prepare

Companion post to my Easy Medical Device podcast episode on IEC 60601-1, 4th Ed., focused on what is shifting across the Working Groups and what RA/QA, Design, Test, and Management teams should do now.

Most organizations will feel the impact long before any formal transition date. The practical shift is that evidence expectations are tightening, scope is becoming clearer, and the standard’s direction is being shaped now through Working Group outputs. Teams that treat this as a design input and planning topic today will avoid late-cycle surprises in test strategy, labeling, and documentation tomorrow.

Translate 4th Edition Direction into Organizational Action

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

Your 4-Part Resource Kit

Listen to Podcast Episode Watch YouTube Interview EMD Magazine #2 Feature 4th ed. Survival Guide

Download One-Pager PDF

Use this one-page briefing handout to kick off internal alignment across RA/QA, Design, Test, Documentation, Supply Chain, and Management.

Read High-Level Overview

This newsletter provides a high-level overview of 4th Edition preparation themes, including transition timing, regulatory positioning, and early planning actions. For deeper technical shifts that drive design inputs and evidence expectations, use the podcast and the one-pager as the primary briefing baseline.

Why this matters for MedTech

The architecture is structured around 12 hazard-based Working Groups, with a much expanded and clearer scope. There are stronger expectations for intended use, user environments, software and PEMS, wireless coexistence, and emerging EMF exposure concepts. These changes will flow into design inputs, QMS documentation, labeling and IFUs, verification and validation evidence, and test strategy.

Across the Working Groups, changes are focused on

Scope and Essential Performance
User environments and intended use
Software and PEMS
International wireless coexistence expectations
EMF exposure concepts
Hazard-based structure

How to use this kit

Brief leadership using the podcast as the shared baseline.
Revisit your intended use, user environments, and understand the changing scope of the standard now.
Assign owners to track the Working Groups most relevant to your product and markets.
Track areas likely to affect:
- QMS documentation
- Labeling and IFUs
- Test strategy and test planning
- Design impacts
- Impact register – track what impact your company expects and what decisions you are making now

Related resources from my earlier Survival Guide

If you want the broader 4th Edition transition kit from my Survival Guide, it includes the MLVx one-pager, my MLVx webinar replay, a summary article, and the slide deck.

Want deeper analysis beyond LinkedIn?

My newsletter is where I publish longer-form breakdowns and structured updates that are not always fully posted on LinkedIn.

Subscribe to the ESC Newsletter Schedule a Call

If your team needs help mapping 4th Edition direction into design controls, QMS, labeling, or test strategy, my team at Eisner Safety Consultants can support you.

What’s NASA & Star Trek have to do with IEC 60601?

leoeisner — Sat, 29 Nov 2025 05:19:05 +0000

Jump to the article Listen to the episode

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 & Home use environments.. And above all, patient safety.

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.

Standards Are Not Rulebooks. They Are Star Maps.

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.

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

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.

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.

Why Star Trek Got So Much Right

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

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:

noise
chaotic motion
temperature shifts
RF interference
unexpected stress

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.

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

The Human Side Of Standards Work

Another meaningful thread that came out in the comments was the human side of the story.

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.

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.

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

Building The Next Generation Of Standards Developers

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.

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.

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.

A Community Effort

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

From Trekkie references to technical reflections to notes from people who simply enjoyed the story

the engagement showed how enthusiastic and thoughtful the MedTech safety community really is.

Where To Listen

If you have not listened yet, I welcome you to take the journey.

“The Star Map to the Future with Leo Eisner The IEC 60601 Guy” on The Podcast.

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

You can listen to the full episode through The Podcast and through the episode links shared on my LinkedIn post and on Faisal’s page.

Closing Thoughts

Thank you to everyone who listened, commented, shared, or supported the conversation.

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

Live Long and Prosper my Friends one and all

Leonard “Leo” Eisner
The IEC 60601 Guy

A quick snapshot of how we help

This one-page overview summarizes our core focus areas in product safety, EMC, risk management, labeling, and training.

You are welcome to read, share, or save this summary if it is helpful for your team.

Download services summary (PDF)

Ready to turn your own “star map” into a safer device?

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.

Schedule a call with Leo Learn more about our work

From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast

leoeisner — Sun, 19 Oct 2025 00:04:30 +0000

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

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 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

leoeisner — Thu, 12 Dec 2024 21:46:24 +0000

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development.

We unpack the upcoming revisions to IEC 60601, 4th ed., focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the future.

Leo provides insights into the intricate process of updating global standards, shares practical advice for compliance, and discusses the role of risk management in ensuring safer, more effective medical devices.

Key Points:

New Modular Approach:
- The updated standard adopts a modular approach (12 working groups focused on specific hazard areas).
- Simplifies updates by consolidating Collateral Standards into the General Standard.
- Aligns better with global regulations.
IEC 60601-1 4th Edition:
- Focuses on addressing various hazards including:
  - physical environment,
  - electrical,
  - thermal and fire,
  - mechanical,
  - user interface (usability, alarms, information supplied by the manufacturer & user interface aspects),
  - materials,
  - optical radiation, and
  - electromagnetic exposure hazards.
New Requirements:
- Introduces new international requirements for wireless coexistence and other cutting-edge technologies (e.g., gas pathways, user interface aspects).
Consolidation of Standards:
- Collateral standards are being consolidated to improve consistency and reduce the update cycle time for the 60601 series.
Timeline and Publication Dates:
- Expected timeline for the fourth edition is 2029-2030.
- Companies need to plan now, though the actual timeline may slip depending on various factors.
Benefits of Proactive Planning:
- Proactive planning and test preparation are essential for regulatory success.
- Staying informed and embracing continuous learning in MedTech are key factors for success.
Practical Advice for Compliance:
- Begin designing for new standards early, even before they are finalized. MedTech design cycles are long.
- Engage with industry groups and standards organizations.
- Use test planning to streamline development and meet regulatory expectations efficiently.
Engaging in the Standards Development Process:
- Manufacturers are encouraged to engage in the standards development process and submit comments.
- This proactive approach can help shape the standards and ensure they are practical and achievable.

These updates aim to enhance safety and performance while keeping pace with technological advancements. Manufacturers need to stay informed and prepare for the impact these changes will have on their product lines and quality systems.

Resources:

Design specification Outline for the fourth edition of IEC 60601-1

Architectural Specification For Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, and Software Used in Healthcare

Only 5 of the 12 Fragments went out for CD on 6 Dec 2024, which were Working Groups (WGs) WG37, 38, 39, 40 & 47 (Fragments 1, 2, 3, 4, & 11 respectively). The status of each of these Fragments is noted below:

Fragment 1 (WG37) Status
Fragment 2 (WG38) Status
Fragment 3 (WG39) Status
Fragment 4 (WG40) Status
Fragment 11 (WG47) Status

The other 7 fragments will go out for CD approximately May ’25 (estimated schedule is my best intelligence). Fragments 5 – 10 & 12. You can look at the SC 62A Work Programme and find the Fragment number in the descriptions for each project on the first 12 projects of the Work Programme to find the status of each Fragment.

If you are a National Committee (NC) member and want to comment on the Fragment depending on your NC rules you may be placing your comments directly into the Online Standards Development (OSD) Platform for the Fragment. Other NCs are collecting the comments and then the NC Secretariat (or similar role) will be responsible for placing all the comments into OSD. Please check with your NC for your specific rules. Details about the OSD platform, How to use OSD, OSD resources (various training and other resources)

New terms and definitions which IEC 60601-1, 4th Ed. will be based on but other Technical Committees will adopt across the Healthcare sector to increase consistency – “International Electrotechnical Vocabulary (IEV) – Part 880: Electrical equipment, electrical systems and software used in healthcare” – IEC Website that has the schedule, list of draft documents. The CDV was released on 13 Dec 2024. If you are a National Committee Member of TC 1, TC 62, SC 62A, SC 62B, SC 62C, SC 62D, TC 65, TC 66, TC 76, TC 87, or SyC AAL you should be able to get access to this document and be able to comment on this document. This document is also being distributed for comment to ISO TC 210 and some additional ISO TCs .

Engage with the Podcast on the LinkedIn Post we’d like to hear from you

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?

Need help with 60601 series standards including EMC? Eisner Safety Consultants can assist with strategic compliance planning for your medical electrical product lines, provide support when FDA or a regulator asks questions for a submission, and more. We deal with EU, US, and other country regulatory requirements, standards, laws, directives, and more. Our team also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more. We work with many test labs for medical safety and EMC and can arrange other testing as well. 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

leoeisner — Mon, 30 Sep 2024 06:46:00 +0000

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.

What Standards Apply to My Device? Podcast #383

leoeisner — Wed, 25 Sep 2024 01:00:00 +0000

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.

How to ID Applicable Standards – Combinate Podcast

leoeisner — Wed, 07 Aug 2024 21:08:23 +0000

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

Join us 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.

FDA Announces Consensus Standards Guidances, Podcast & Webinar

leoeisner — Sat, 22 Sep 2018 22:03:32 +0000

On September 13, 2018 the FDA posted 2 Guidance Documents

Podcast on Standards & FDA’s Release of these Guidance Documents

FDA’s Captain Scott Colburn and Leo Eisner of Eisner Safety Consultants did a podcast with Jon Speer of Greenlight Guru on Standards Development of the IEC 60601 Series and these recently released Guidance documents. Listen to this conversation…

Some of items of note with the Final FDA Guidance include:

FDA can now Recognize a standard and place on the Recognized Consensus Standards db prior to a formal Federal Register updates
Declaration of Conformity (DOC) to follow requirements of ISO 17050-1 or as specified in the Final Guidance in section IV. A. (1)
DOC process different for Consensus Standards that are horizontal, process-oriented, or that include choices relating to test methods, test selection, or have guidelines that apply to a broad range of device types and safety issues then FDA recommends submitters follow ISO 17050-2 – Supplier’s DOC – Supporting Documentation per section IV. A. (2) of the Final Guidance

IEC 60601-1, edition 3.2 (draft) and it’s collateral standards (IEC 60601-1-XX) are being updated and Leo discusses why this is happening, the timing and some of the impacts on manufacturers and design houses in this podcast.

FDA Guidance Documents – Additional Information

The draft guidance will be open for public comments and suggestions for 60 days at https://www.regulations.gov under Docket Number: FDA-2018-D-2936.

The Appropriate Use of Voluntary Consensus Standards final guidance describes the appropriate use and documentation of consensus standards for premarket submissions and how FDA staff intends to rely on consensus standards during the review process. Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information to address issue(s) the standard was intended to address. This guidance provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions.:”

Webinar about the Appropriate Use Final Guidance:

FDA will be hosting a Webinar on Thursday, October 25th, 2018. The webinar will be for manufacturers & others interested in learning more about the Appropriate Use final guidance. No registration is required.

Time: 1:00 – 2:00pm EST (To ensure you are connected, dial-in prior to the start of the webinar)
To hear the presentation and ask questions:
Dial: 800-475-0481, International Callers Dial: 1-517-308-9467; Conference Number: 8090070; Passcode: 2387655
To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW8090070&p=2387655&t=c
Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

Need help sorting out the proper medical device standards that apply to your device submission for the US, Canada, EU or elsewhere? Contact Leo “the IEC 60601 Guy” Eisner to help you thru this process at Leo at EisnerSafety dot com or schedule a call with Leo.