Eisner Safety ConsultantsRegulatory & Safety Experts for Global Medical Device Approvals2026-06-11T05:24:31Zhttps://eisnersafety.com/feed/atom/https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.pngleoeisner<![CDATA[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/?p=85212026-06-11T05:24:31Z2026-06-12T07:00:00ZPresenting 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.
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:
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.
]]>leoeisner<![CDATA[IEC 60601, 4th Edition: What’s Changing and How to Prepare]]>https://eisnersafety.com/?p=84862026-03-01T09:36:37Z2026-02-28T21:33:00Z
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.
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.
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.
]]>leoeisner<![CDATA[Dec 22, 2025: FDA Updated Its Recognized Consensus Standards db 100+ New Or Updated Standards]]>https://eisnersafety.com/?p=84062026-01-10T09:18:59Z2026-01-04T11:15:53ZFDA Updated Its Recognized Consensus Standards db
In late December 2025, the FDA expanded its Recognized Consensus Standards Database, adding more than 100 new or updated standards. Some are eligible for use under the ASCA Program, while others carry important implications for design, testing, labeling, and overall regulatory strategy.
Regulatory expectations around standards are shifting earlier in the product lifecycle. Standards are no longer something teams can simply “handle at test.” Reviewers increasingly expect standards interpretation, risk decisions, and test strategies to be visible and justified during design reviews and technical documentation development. This reinforces why understanding not just which standards are recognized, but how they are recognized and applied, matters more than ever.
What the latest FDA update included
The scope of this database expansion spans a wide range of medical device technologies, including medical electrical equipment, IVDs, software-driven devices, imaging systems, interoperability standards, and labeling-related standards.
Beyond simply identifying newly recognized standards, the changes highlight how recognition status, ASCA eligibility, and extent of recognition can materially affect how conformity is demonstrated, how evidence is presented, and how submissions are reviewed.
Over the past year, I’ve been sharing what I’m seeing based on feedback gathered from many sources, including my Eisner Safety Consultants experts and discussions across the community with regulators, standards developers, test labs, and manufacturers. The goal is practical clarity: what changed, what it means, and what teams should do next as they navigate evolving standards expectations and regulatory requirements.
IEC 60601 / 80601 standards in the update
For manufacturers of medical electrical equipment, the December 22, 2025 update includes
several standards from the IEC 60601 and 80601 series.
These standards remain central to demonstrating basic safety and essential performance
for medical electrical equipment. However, recognition alone does not mean every clause
or requirement is fully accepted without qualification.
Standards called out in the December 22, 2025 update
(from the FDA database extract)
Standard
Title (abbreviated)
FDA Recognition No.
Extent of Recognition
IEC 80601-2-70:2025
Sleep apnoea breathing therapy equipment
1-199
Complete
IEC 60601-2-31:2020
External cardiac pacemakers
3-201
Complete
IEC 60601-2-34:2024
Invasive blood pressure monitoring
3-202
Complete
IEC 80601-2-49:2024
Multifunction patient monitoring equipment
3-203
Partial*
* Partial recognition. The following part(s) of the standard is (are) not recognized:
Subclause 202.8.101 “IMMUNITY test setup” – Reference to table height (>= 0,4 m) for IMMUNITY testing in Figure 202.101. Refer to Rationale for Recognition for explanation of partial recognition.
EMC context within the IEC 60601 / 80601 framework
IEC 60601-1-2 remains the primary EMC standard within the IEC 60601 series.
However, other IEC 60601 standards can and do include EMC-related requirements.
Applicability must be assessed standard by standard, based on the specific requirements
of each applicable document.
This context becomes especially important when considering how EMC expectations are
addressed across different standard families, including IVD-specific EMC requirements
discussed next.
IVD EMC and IEC 61326-2-6
A notable change reflected in the FDA Recognized Consensus Standards Database is the
inclusion of IEC 61326-2-6 Edition 4 as a Recognized Consensus Standard,
with ASCA eligibility under the ASCA Program, effective July 28, 2025.
This is significant because IEC 61326-2-6 is the primary EMC standard used to
demonstrate electromagnetic compatibility for IVD medical equipment, and its
inclusion under ASCA directly affects how EMC conformity evidence may be presented in FDA
submissions.
However, ASCA eligibility alone does not guarantee streamlined review.
For manufacturers intending to rely on ASCA pathways for IVD EMC:
Test lab scope must be verified as active for the specific standards and applicable editions being claimed.
If a standard or edition is not within a laboratory’s ASCA-accredited scope,
manufacturers cannot rely on an ASCA Summary Test Report for that standard.
In those cases, full EMC test reports remain necessary, and FDA review timelines are typically longer.
As of early January 2026, there are no ASCA-accredited laboratories that reflect
IEC 61326-2-6 Edition 4 within their active scope. This creates a practical timing
and planning consideration for manufacturers preparing IVD submissions that intend to
leverage ASCA.
This gap does not change the applicability of IEC 61326-2-6 itself, but it does affect how
conformity evidence can be packaged and reviewed until laboratory scopes are updated.
ISO 15223-1 Amendment 1:2025 and labeling implications
Authorized Representative symbol changes and labeling impact
ISO 15223-1 Amendment 1:2025 introduces a substantive correction to the
requirements for the Authorized Representative symbol that has
direct regulatory and labeling implications across multiple markets.
This change is implemented through a revision to Clause 5.1.2, which
governs how the Authorized Representative symbol is applied.
Clause 5.1.2 – prior to Amendment 1:2025
“This symbol shall be accompanied by the name and address of the authorized representative,
adjacent to the symbol.”
Under this wording:
The symbol itself did not explicitly encode the jurisdiction
The convention of using “EC REP” persisted in practice, even after the transition from the MDD & IVDD to EU MDR and IVDR
This created ambiguity for non-EU markets and for
products marketed globally under different regulatory frameworks
Clause 5.1.2 – after Amendment 1:2025
“The [XX] text of the symbol shall be replaced by either the two-letter country code or the
three-letter country code defined in ISO 3166-1 or other text required by the authority
having jurisdiction.
This symbol shall be accompanied by the name and address of the authorized representative
adjacent to the symbol.”
Key changes introduced by this amendment:
The Authorized Representative symbol must identify the jurisdiction represented
The jurisdiction identifier is no longer implicit or assumed
Country-specific representation is now explicitly required using ISO 3166-1 codes or authority-mandated text
This change aligns the symbol requirements with:
EU MDR and IVDR expectations for EU Countries
Non-EU regulatory frameworks that require local authorized representation
Global labeling clarity for multi-market products
Practical application of the revised requirement
International example
Used for countries outside the EU, such as Switzerland or the United Kingdom.
Examples:
CH REP for Switzerland
UK REP for the United Kingdom
Convert from EC Rep to International two-letter country code Authorized Representative Symbol
EU example
Used for EU Member States.
Convert from EC Rep to EU Rep Authorized Representative Symbol
Labeling and change-control implications
Symbol changes cascade into artwork, IFUs, packaging, and labeling change control.
This affects and has significant impact on:
Device labels
IFUs
Packaging artwork
Labeling control procedures
These changes must be assessed and implemented through formal labeling change processes,
not treated as isolated graphic updates.
Need help turning standards updates into practical actions?
My team & I at Eisner Safety Consultants supports medical device, diagnostic, and combination product manufacturers by translating standards into practical design inputs, test strategies, and documentation approaches aligned with FDA and other market expectations.
Add your perspective to the discussion on the December FDA standards update, including ASCA, IEC 60601/80601, IVD EMC,
ISO 15223-1 A1 & how these changes play out in practice.
Medical Device Compliance & Certification Summit – Why It Matters?
Medical device and diagnostic compliance expectations are shifting earlier in the product lifecycle.
IEC 60601 and related standards are no longer something teams can “handle at test.” Regulators increasingly
expect standards interpretation, risk decisions, and test strategy to be visible and justified during
design reviews and technical documentation development.
This shift is showing up in real ways – deeper design reviews, tougher pre-submission questions, and increased scrutiny
of how standards were applied, not just whether a final test report exists.
To address this reality, Eisner Safety Consultants (ESC) is working with Nemko to deliver a three-day,
in-person Medical Device Compliance & Certification Summit focused on how standards, testing, and regulator expectations
intersect in real programs.
A focused, three-day program for engineering, regulatory, and compliance teams navigating IEC 60601, IEC 61010, EMC and RF requirements,
certification strategy, and regulator guidance documents across FDA, EU, and other markets.
In-Person Training & Live Workshops
February 2–4, 2026
Carlsbad Inn Beach Resort, 3075 Carlsbad Blvd, Carlsbad, CA 92008
Designed for teams preparing new medical devices or diagnostics for market, working through recurring EMC or RF failures,
or tightening FDA or EU MDR technical documentation ahead of submission or surveillance review.
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.
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.
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.
]]>leoeisner<![CDATA[From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast]]>https://eisnersafety.com/?p=83542025-10-19T00:04:30Z2025-10-19T00:04:30Z
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.
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.”
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.
]]>leoeisner<![CDATA[IEC 60601-1, 4th Edition Survival Guide – Why It Matters For MedTech]]>https://eisnersafety.com/?p=83262025-10-01T09:48:37Z2025-09-30T09:23:00Z
IEC 60601-1, 4th Edition Survival Guide – Why It Matters For MedTech
The 4th Edition of IEC 60601-1 is no longer a future concern. Eleven of the twelve hazard fragments (WGs 37–48) have circulated Committee Drafts (CDs). All fragments have issued first CDs (WG 47 is at CD2), except WG 45 (Optical Radiation Hazards).
That means manufacturers, design houses, trade associations, test houses, and regulators must follow the working group outputs closely. If you cannot stay directly engaged in National or International (IEC) committees, you will need trusted expert guidance. These changes will impact design, QMS, labeling and IFUs, documentation, and test strategies.
Download the One-Pager: 9 Things RA/QA Leaders Must Know
Quick to read and easy to share with RA/QA, Design, Documentation, Supply Chain, Test, and Management. Use it to brief teams and kick off transition planning for IEC 60601-1, 4th Edition.
First-round CD comment periods are closed; the Compilation of Comments (CC) now drives edits in each WG. Expect a first wave of CD2s planned for early Dec 2025 after the Nov 2025 Milan work week, and a second wave following the Apr 2026 Shanghai meetings around Jun 2026. Stay current with CDs and CCs — or engage experts — because changes here will flow into design inputs, QMS, labeling/IFUs, V&V, and documentation.
Working Group
Key Document
CD Status
CD Comment Period
Compilation of Comments / Next Milestone
WG 37 – General requirements
62A/1628/CD
1st CD circulated Dec 2024
closed Feb 28, 2025
62A/1656/CCresolve by Dec ’25; iss CD2
WG 38 – Environmental & electromagnetic environments
62A/1630/CD
1st CD circulated Dec 2024
closed Feb 28, 2025
62A/1658/CCresolve by Dec ’25; iss CD2
WG 39 – User interface & alarm hazards
62A/1631/CD
1st CD circulated Dec 2024
closed Feb 28, 2025
62A/1659/CCresolve by Dec ’25; iss CD2
WG 40 – Materials hazards
62A/1632/CD
1st CD circulated Dec 2024
closed Feb 28, 2025
62A/1660/CCresolve by Dec ’25; iss CD2
WG 41 – Programmable electrical medical systems
62A/1675/CD
1st CD circulated Jun 2025
closed Sep 12, 2025
62A/1695/CCresolve by Jun ’26; iss CD2
WG 42 – Electrical hazards
62A/1676/CD
1st CD circulated Jun 2025
closed Sep 12, 2025
62A/1696/CCresolve by Jun ’26; iss CD2
WG 43 – Mechanical hazards
62A/1677/CD
1st CD circulated Jun 2025
closed Sep 12, 2025
62A/1697/CCresolve by Jun ’26; iss CD2
WG 44 – Thermal & mechanical energy hazards
62A/1673/CD
1st CD circulated Jun 2025
closed Sep 12, 2025
62A/1698/CCresolve by Jun ’26; iss CD2
WG 45 – Optical radiation hazards
—
No CD circulated yet
Next: issue CD1: TBD
Resolve by: TBD; Next milestone: compile CC after CD1
The replay provides the why — why regulators are focusing on scope and user environments, how expanded software/PEMS requirements shift the burden of evidence, and why wireless coexistence is no longer optional outside the US.
This article organizes the hour-long webinar into a reference that RA/QA leaders and design managers can use to pinpoint pain points to focus on to avoid the fire drills of last-minute planning.
How to use this survival kit
Kick off a cross-functional session using the one-pager as the agenda
Watch replay segments together (software, EMC, labeling, etc.)
Assign owners for each of the 12 hazard Working Groups across RA/QA, Design, Test
Use the article as a quick reference to keep momentum
Track WG outputs and rely on your internal or external experts
one-pager for overview, the replay for context, the article for detail, and the slide deck for depth give your team a GPS starting point for 4th Edition readiness.
How We Can Help
If your team needs help mapping the 4th Edition into your design controls, QMS, labeling, or testing strategy, my team at Eisner Safety Consultants and I are ready to support you.
Explore more insights on my blog or listen to past podcasts
]]>leoeisner<![CDATA[What IVD Manufacturers Need To Know About IEC 61326-2-6:2025]]>https://eisnersafety.com/?p=80392025-09-02T18:21:27Z2025-08-31T21:28:00Z
IVD EMC and IEC 61326-2-6:2025
FDA Recognition & the Tougher Road Ahead
FDA fully recognized IEC 61326-2-6:2025 and included it in ASCA on July 28, 2025.
Here’s what changes and how IVD manufacturers should respond.
Bottom line: many will assume this removes the burden of IEC 60601-1-2 compliance.
The reality is more nuanced. Parts of 60601-1-2 were incorporated into the updated 61326-2-6, and
Essential Performance and risk management remain critical.
The FDA 2022 EMC Guidance still applies.
The technical reality – 4 key takeaways
Global implications
IEC 61326-2-6:2025 applies internationally, not just in the United States.
Update your compliance strategy across markets, not only for FDA submissions.
What manufacturers should do now
If your EMC test plans, risk analysis, or labeling still reference IEC 60601-1-2 or IEC 61326-2-6:2020 for IVDs,
it’s time to recheck your EMC strategy
Refresh your risk management file and test plans to align with 61326-2-6:2025.
Train teams on how Essential Performance still factors into acceptance criteria and test objectives.
Anticipate ripple effects from CISPR 11:2024 when 61326-1 updates land.
At Eisner Safety Consultants, we have multiple EMC experts ready to support you. If you’d like to schedule a
free 30-minute meeting
with me, Leo, The IEC 601 Guy, to discuss your needs, I’d be glad to help.
]]>leoeisner<![CDATA[🎥 IEC 60601-1 4th Edition: Design Controls And QMS Impacts You Need To Know 📣📣]]>https://eisnersafety.com/?p=78682025-08-31T09:51:35Z2025-08-25T09:31:00Z
Impacts on IEC 60601-1, 4th Ed. – Webinar Recap and Industry Reactions
Insights from 110+ MedTech professionals on the upcoming 4th Edition and its impact on design controls, QMS, and labeling.
On August 15, 2025, I had the privilege of presenting the Impacts on IEC 60601-1, 4th Edition webinar as part of MLVx Friday In-Focus. The turnout was incredible, with more than 110 MedTech professionals from around the world joining. Startups, SMEs, large manufacturers, test labs, and regulators were all represented.
We unpacked the drivers and major changes in the upcoming 4th Edition, and the discussion didn’t stop when the webinar ended. Some of the most valuable insights came afterward in the LinkedIn conversations that followed.
From the comments and follow-up conversations, four major themes stood out:
SME vs Large Corp Burden – Smaller companies worry the 4th Edition requirements could hit them harder than large corporations with more resources.
National & International Committee Involvement – Many are realizing that participating in standards development, even at the national level, gives manufacturers a seat at the table. Being involved internationally is even more powerful if you can swing it.
Rationale Behind Requirements – The Design Specification requires a rationale for each requirement of the standard. This is not fully addressed in Ed. 3.2, so the change should help improve industry understanding of the standard going forward.
Impacts on Design Controls, QMS, and Labeling – These changes are not just “paper exercises.” They will reshape how manufacturers approach design controls, QMS integration, and labeling processes across the entire product lifecycle.
Replay Video
If you missed the live session or want to revisit the details, here’s the full webinar replay:
As the IEC 601 Guy, I’ve been deeply involved in the development of IEC 60601-1, not just for this edition but also for the previous edition. The 4th Edition is shaping up to be one of the most impactful yet, especially in how it connects to design controls, supplier oversight, and QMS processes.
Conversations like these are important because they highlight the real-world concerns of manufacturers, regulators, and test labs. They help ensure implementation of the standard is proactive, not reactive.
How We Can Help
If your team needs help mapping these 4th Edition changes into your design controls, QMS, or testing strategy, my team at Eisner Safety Consultants and I are here to support you.
Together, we can make sure these changes lead to safer devices, smoother regulatory pathways, and stronger compliance strategies.
]]>leoeisner<![CDATA[Major changes to IEC 60601-1 are closer than you think]]>https://eisnersafety.com/?p=78542025-08-15T19:06:34Z2025-08-15T18:53:33Z
Once the 4th Edition is published, redesigns and QMS updates will be far more costly.
Direct insights from someone in the development of IEC 60601-1, 4th Edition
Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.
Event Recap – MLVx Friday In-Focus
On Friday, August 15, the MLVx Friday In-Focus with Sean Smith brought together Leonard (Leo) Eisner, The IEC 60601 Guy, and 110+ professionals from around the globe, including the UK, Romania, US, France, Switzerland, Germany, Finland, and Pakistan, representing medtech manufacturers, regulators, test houses, and standards developers.
We focused on the impact of IEC 60601-1, 4th Edition, the global standard that defines safety and essential performance for medical electrical equipment, and what’s coming that many companies are still not prepared for.
The highlight was an impromptu expert panel with leaders in risk management, software, cybersecurity, regulatory submissions, and combination devices. Together, we tackled questions from every angle, sharing real-world insights on design, testing, and compliance challenges. The discussion showed exactly what’s possible when top experts collaborate to help the industry prepare for disruptive change.
(Full presentation available for download at the bottom of this post.)
Unlock Your IEC 60601-1 Insider Advantage
Mitigate Risks: Spot disruptive changes early, prevent costly redesigns, and align documentation ahead of competitors
Accelerated Compliance: Seamlessly integrate evolving requirements into your development pipeline
Leadership Insight:The IEC 60601 Guy and our expert team track areas of interest for your organization based on draft documents
Behind Closed Doors: Access knowledge while it’s still being developed
Ready to Leap Ahead? Let’s turn this insider pipeline into your 4th Edition fast-track
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. 
Podcast episode where I joined Faisal Kamal, “The Star Map to the Future.”
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. 
, not a riddle
Your 4-Part Survival Kit
Download One-Pager PDF
Watch Webinar Replay
Summary Article
Download Slide Deck
WG Status at a Glance
Schedule a call with me, Leo, the IEC 601 Guy
Schedule a Call
Download Slides
+1-503-709-8328 