60601-1-9 – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Thu, 11 Jun 2026 05:24:31 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png 60601-1-9 – Eisner Safety Consultants https://eisnersafety.com 32 32 Keep the Patient at the Center: My Full Week at IMSC26 (and Why Getting Ahead of IEC 60601-1, 4th Edition Is Really About People) https://eisnersafety.com/2026/06/12/keep-the-patient-at-the-center-my-full-week-at-imsc26-and-why-getting-ahead-of-iec-60601-1-4th-edition-is-really-about-people/?utm_source=rss&utm_medium=rss&utm_campaign=keep-the-patient-at-the-center-my-full-week-at-imsc26-and-why-getting-ahead-of-iec-60601-1-4th-edition-is-really-about-people Fri, 12 Jun 2026 07:00:00 +0000 https://eisnersafety.com/?p=8521 Leo Eisner presenting the impact of IEC 60601-1, 4th Edition at IMSC26
Presenting at IMSC26: getting ahead of IEC 60601-1, 4th Edition
📬 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 Eisner and Caitlin Brady at TÜV Rheinland
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 Pairet and Leo Eisner
Jean-Yves & Leo during the CEF / CEP workshop, taking a short break

The talks that stuck with me

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

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

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

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

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

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

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

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

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

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

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

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

AI, human factors, and more sessions worth your time

My associates at Prodct Studio, Christie Johnson and Devon C. Campbell, ran a fantastic Tuesday workshop, “The AI-Powered MedTech Professional.” They also know how to host. I may have “dragged” a few 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
From NASA to IEC 60601: A Lifelong Trek for Safer Devices

What I am carrying back to the committees

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

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

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

The part that matters most

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

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

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

I joined Duane Mancini on the Project Medtech Podcast to share how I became known for IEC 60601, why the series is a roadmap you can follow, and what 4th Edition changes mean for design, QMS, and documentation.

Episode 235

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

A quick personal note

Nobody starts at the top as “The IEC 60601 Guy.” My path ran through early days at NASA, many years in test labs, and deep work in standards committees. What stuck with me is simple — stay curious, do the work, and show the work. That’s how we turn a dense standard into a practical plan.

Key takeaways from the episode

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

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

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

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

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

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

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

What peers said

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

— Beat Keller

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

— Ronald Boumans

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

— Tibor Zechmeister

Continue the discussion on this topic on LinkedIn

How We Can Help

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

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

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

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

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

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

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

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

What the Industry Is Talking About

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

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

Replay Video

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

👉 Download the slides here

Why This Matters

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

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

How We Can Help

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

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

Keep the Conversation Going

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

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

]]> Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X https://eisnersafety.com/2025/03/31/join-me-for-an-interactive-workshop-identifying-standards-guidances-turn-standards-into-your-competitive-advantage-10x/?utm_source=rss&utm_medium=rss&utm_campaign=join-me-for-an-interactive-workshop-identifying-standards-guidances-turn-standards-into-your-competitive-advantage-10x Mon, 31 Mar 2025 22:50:00 +0000 https://eisnersafety.com/?p=7796

Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the 10X Medical Device Conference in Newport Beach, Ca on May 7 – 8, 2025. Turn Medical Device Standards into Your Competitive Advantage, and discover practical strategies to leverage standards, avoid costly errors, and accelerate your product development cycle.

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

  • Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines
  • Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions
  • Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.
  • Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays
  • Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

I want to thank Sean Smith and his team from 10X for all his help and dedication for putting on this event. He is doing an amazing job and please contact him if you are interested.

Need help with standards?

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

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

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

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

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

When: Tuesday, June 25, 2024  

Time: 11:00 a.m. – 12:00 p.m. EDT 

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

Sign up for this webinar

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

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

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

]]> Draft EUDAMED Roadmap of Modules https://eisnersafety.com/2023/10/21/draft-eudamed-roadmap-of-modules/?utm_source=rss&utm_medium=rss&utm_campaign=draft-eudamed-roadmap-of-modules Sat, 21 Oct 2023 21:10:44 +0000 https://eisnersafety.com/?p=7365

Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.

Q4’ 2027: Article 123 (3) (d) MDR/113 (3) (f) IVDR

  • Actor (Economic Operators register in EUDAMED; Supervising Entities has access to EUDAMED that is not public),
  • Certificates (Active, suspended, reinstated, withdrawn, refused, other restrictions on certificates),
  • MSU (Evaluation of devices on the market by Competent Authorities),
  • Vigilance (& Post Market Surveillance), and
  • CI/PS (Before a device is placed on the market – Clinical Investigation and Performance Study)

Q2’ 2029: Article 123 (3) (e) MDR/113 (3) (a) IVDR

  • Devices (Based on UDIs registered in EUDAMED) and
  • Certificates (see above)

* For a brief explanation of EUDAMED modules refer to the below

Need help with Medical Electrical Equipment standards (60601/80601 series) including Safety/EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

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

]]> IEC 60601 Amendments Presentation Now on MDG Premium https://eisnersafety.com/2021/08/04/iec-60601-amendments-presentation-now-on-mdg-premium/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-amendments-presentation-now-on-mdg-premium Wed, 04 Aug 2021 18:10:48 +0000 https://eisnersafety.com/?p=6972

Joe Hage graciously invited me to present on July 30 to his MDG premium group on “IEC 60601 Amendments & What’s in the future for Medical Electrical Equipment”. We had a great conversation with about 35 or so people from around the world. They were from Ireland, the Netherlands, India, the US, and elsewhere in the conversation, with questions throughout and at the end too.

I included some new information about the FDA ASCA Pilot Program (new lab info) and also some about the status of some of the Amendment standards and where the US and EU standards are at in terms of adoption.

Enjoy the presentation. It’s at https://youtu.be/yS0xfFX0VpU – MDG Premium’s special YouTube Channel

By the way I recently joined the MDG premium group and you should too. It’s a great way to meet others in the industry and trade ideas and ask questions of experts in the field.

Need help with the IEC 60601 Amendments, work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator ask 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. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com or through our contact form at https://eisnersafety.com/contact_eisner_safety/.

]]> EU Commission MDR & IVDR Standardization Request List – Will it Succeed? https://eisnersafety.com/2021/04/21/eu-commission-mdr-ivdr-standardization-request-list-will-it-succeed/?utm_source=rss&utm_medium=rss&utm_campaign=eu-commission-mdr-ivdr-standardization-request-list-will-it-succeed Wed, 21 Apr 2021 21:03:20 +0000 https://eisnersafety.com/?p=6888

COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR.  One of the issues is the HAS consultant has issued a negative assessment on EN ISO 14971 which the CEN/CLC JTC3 leadership is working with the HAS consultant to address the issues and to draft acceptable European annexes so Harmonization can occur for the standard.  Many of the standards on the list in M/575 reference to EN ISO 14971 so it is highly likely that CEN and CENELEC will reject this newest version of the EU Commission Standardization Request again and we won’t have any Harmonized Standards by the Date of Application (26 May 2021) for the MDR which will cause lots of problems for manufacturers and Notified Bodies and cause more delays for the MDR & likely even for the IVDR I’m sorry to say.  Also, the MDCG 2021-5 “Guidance on standardisation for medical devices” doesn’t seem to clarify when harmonized standards are not published through the Offical Journal of the EU what to do.  In section 3.1 mentions Harmonized standards are voluntary with respect to the MDR & IVDR as they were for the MDD, AIMDD, & IVDD.  The closest the MDCG gets to it is to use the “State of Art” standards approach in section 3.5.

Another important observation is all the newest versions of the General & Collateral IEC 60601 Standards that were issued Summer of 2020 (EN versions were issued later in the year) are listed in Annex I of the EU Commission Standardization Request as the deadline to adopt these standards by 27 May 2024 — These are EN 60601-1, ed. 3.2; EN 60601-1-2, ed. 4.1; EN 60601-1-3, ed. 2.2; EN 60601-1-6, ed. 3.2; EN 60601-1-8, ed. 2.2; EN 60601-1-9, ed. 1.2; EN 60601-1-10, ed. 1.2; EN 60601-1-11, ed. 2.1; & EN 60601-1-12, ed. 1.1 – The Particular Standards EN 60601-2-XX or EN ISO 80601-2-XX listed are primarily based on the previous versions of the General & Collaterals of IEC 60601 standards on the M/575 list so this will likely cause conflicts vs the listed new standards mentioned here.

Follow the full discussion and updates to this post on LinkedIn

Confused this is what Eisner Safety Consultants experts deal with all the time for countries for these and many other standards, regulations, laws, directives, and more. Leo Eisner is an expert on standards development and sit on many standards committees. Let us help you through this process. Need help with Essential Performance. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com or through our contact form at https://eisnersafety.com/contact_eisner_safety/.

]]> IEC 60601-1 Amendment 2 Just Released – Join for a Webinar on Changes & More https://eisnersafety.com/2020/08/26/iec-60601-1-amendment-2-just-released-join-for-a-webinar-on-changes-more/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-amendment-2-just-released-join-for-a-webinar-on-changes-more Wed, 26 Aug 2020 01:16:20 +0000 https://eisnersafety.com/?p=6819 IEC 60601-1 Amendment 2 (IEC 60601-1:2005 +A1:2012 + A2:2020) has been in the making since 2015 (officially) along with the other published Amendments (IEC 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, & 60601-1-12). It was published on 20 August 2020 on the IEC website and you can obtain it either as a separate Amendment (A2) or as a consolidated edition (CSV). Unfortunately, you can’t obtain a red-line of the document showing from the previous edition. I was hoping for that myself as so much easier to see the changes. Also, I don’t recommend purchasing it from the IEC website as the standards there are usually too expensive to purchase. I usually go to the Estonian Standards website but since the standard won’t be Harmonized for many years that won’t help. So, I suggest going to your local standards distributor site such as IHS, SAI Global, or TechStreet are some of the more common ones.

So are you ready for all the changes of Amendment 2 of IEC 60601-1 and all the Amendments?

Join us for a live free webinar on an Insider’s look at IEC60601 Amendments: detailed guidance from a committee member responsible for changes – Aug 27, 10 AM PT/ 1 PM ET

With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC60601 series is massive, creating a swell of confusion around understanding the updates & how to transition for compliance.

Greenlight Guru has teamed up with Leonard Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendments Project.

This in-depth webinar will cover clarifying details around the massive changes of the Amendments Project, provide guidance on updated standards already published, insider knowledge into updated standards not yet published & what to expect, & how to prepare accordingly for the impact it will have on your firm and product lines.

SOME OF THE CHANGES WE WILL COVER INCLUDE: 

  • Updates to IEC 60601-1 (Medical Electrical Equipment)
  • Updates to IEC 60601-1-2 (EMC)
  • Updates to IEC 60601-1-8 (Alarms)
  • Impacts of standard changes on:
    • Design
    • Regulatory approvals (i.e. FDA vs EU Notified Body – current vs new standards)
    • Safety certifications
    • Labeling / markings / packaging
    • Tests/ retesting
    • Essential Performance
    • Risk Management File
    • Usability Engineering File
    • Software Life Cycle Process
  • Q&A session

WHO SHOULD ATTEND?

  • R&D Engineers and Management
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Clinical Affairs Professionals and Management
]]> Insider’s look at the IEC 60601 Amendments: detailed guidance from committee member responsible for changes https://eisnersafety.com/2020/08/14/insiders-look-at-the-iec-60601-amendments-detailed-guidance-from-committee-member-responsible-for-changes/?utm_source=rss&utm_medium=rss&utm_campaign=insiders-look-at-the-iec-60601-amendments-detailed-guidance-from-committee-member-responsible-for-changes Fri, 14 Aug 2020 04:45:52 +0000 https://eisnersafety.com/?p=6799

It’s becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape.

With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC 60601 series is massive, creating a swell of confusion around understanding the updates and how to transition for compliance.

We’ve teamed up with Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendment Project.

This in-depth webinar will cover clarifying details around the massive changes of the IEC 60601 Amendments, provide guidance on the updated standards already published, insider knowledge into the updated standards not yet published and what to expect, and how to prepare accordingly for the impact it will have on your firm and product lines.

SPECIFICALLY THIS WEBINAR WILL COVER:

  • Updates to IEC 60601-1 (Medical Electrical Equipment)
  • Updates to IEC 60601-1-2 (EMC)
  • Updates to IEC 60601-1-8 (Alarms)
  • Impact of standard changes on:
    • Design
    • Regulatory approvals (i.e. FDA vs EU Notified Body – current vs new standards)
    • Safety certifications
    • Labeling / markings / packaging
    • Tests/ retesting
    • Essential Performance
    • Risk Management File
    • Usability Engineering File
    • Software Life Cycle Process
  • Q&A session

Who Should Attend?

  • R&D Engineers and Management
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Clinical Affairs Professionals and Management
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ABOUT GREENLIGHT GURU

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ABOUT EISNER SAFETY CONSULTANTS

Eisner Safety Consultants supports your regulatory, quality systems, product safety, EMC, and engineering needs. Our experts speed your way to on-time product approvals via safety and regulatory agencies. We provide assistance with U.S., Canadian, European, & other international regulations. You can see a full list of the service offerings from Eisner Safety Consultants by visiting their website to learn more.

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