ISO – Eisner Safety Consultants

Medical Device Compliance & Certification Summit – Why It Matters?

leoeisner — Tue, 23 Dec 2025 23:30:37 +0000

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.

Registration Summit Details

Who this summit is designed for

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

What attendees will learn

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

How Eisner Safety Consultants Can Help

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

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

Registration Summit Details

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

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

Podcast Feature

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

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

Episode 235

Listen on Web Open Spotify

A quick personal note

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

Key takeaways from the episode

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

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

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

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

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

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

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

What peers said

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

— Beat Keller

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

— Ronald Boumans

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

— Tibor Zechmeister

Continue the discussion on this topic on LinkedIn

How We Can Help

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

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

Major changes to IEC 60601-1 are closer than you think

leoeisner — Fri, 15 Aug 2025 18:53:33 +0000

Once the 4th Edition is published, redesigns and QMS updates will be far more costly.

Direct insights from someone in the development of IEC 60601-1, 4th Edition

Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.

Event Recap – MLVx Friday In-Focus

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

We focused on the impact of IEC 60601-1, 4th Edition, the global standard that defines safety and essential performance for medical electrical equipment, and what’s coming that many companies are still not prepared for.

The highlight was an impromptu expert panel with leaders in risk management, software, cybersecurity, regulatory submissions, and combination devices. Together, we tackled questions from every angle, sharing real-world insights on design, testing, and compliance challenges. The discussion showed exactly what’s possible when top experts collaborate to help the industry prepare for disruptive change.

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

Unlock Your IEC 60601-1 Insider Advantage

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

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

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

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

🎩 Get your reviewer’s hat on – IEC 60601-1, 4th Edition Draft Fragments Have Dropped‼️ 🚀

leoeisner — Sat, 28 Jun 2025 01:09:39 +0000

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

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

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

These fragments cover hazards related to: • Electrical, mechanical, thermal, and fire • Software & PEMS (SaMD, SiMD, firmware, OS…) • EM Disturbance, wireless coexistence, ionizing radiation, and electromagnetic exposure (EMF)

The International comment deadlines start closing August 29th, with more due by September 12th. National deadlines close much sooner (does your summer holiday schedule conflict?)

Don’t wait for the FDIS – get involved now or get caught off guard later.

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

Here’s the who’s who of the Working Groups behind the fragments with CD1 to issue 20 July:

• WG 41 – PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards WG 41 link

• WG 42 – Electrical hazards WG 42 link

• WG 43 – Mechanical hazards WG 43 link

• WG 44 – Thermal and fire hazards WG 44 link

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

• Fragment 11 – WG 47: Electromagnetic exposure hazards (not optical or ionizing but including SAR) WG 47 link CD2, closes 29 August

• Fragment 10 – WG 46: Ionizing radiation hazards WG 46 link CD1, closes 5 September

• Fragment 12 – WG 48: Electromagnetic disturbances (including wireless coexistence) WG 48 link CD1, closes 5 September

The early pack of CD1 Fragments released late last year

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

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

Who Should Be Reviewing

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

What You Need to Do

Review the Drafts & the 4th ed. Design & Architecture Specs Now • Assign key experts by hazard/WG • Map against your design controls: Design Spec • Understand the architecture spec: Architecture Spec
Track IEV Part 880 Terms • Stay aligned with the evolving definitions: Terms & Definitions
Analyze Impact to Products • Run gap assessments • Identify implications for design, testing, and documentation
Submit Comments • Through your National Committees (ANSI, BSI, DIN, etc.) • Clear, technically sound feedback = meaningful influence
Update Design & Risk Inputs • Don’t wait for the final version to start aligning
Integrate Into Product Roadmaps • Work with R&D, QA/RA, and exec sponsors • Flag projects needing early adaptation
Engage the Right Experts • Join WGs or partner with someone who’s inside () • Stay active – your input now shapes what becomes final
Invest in Training • Get smart now to avoid surprises later

Don’t wait for the FDIS – get involved now or get caught off guard later.

Need help with standards?

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

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

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

Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

leoeisner — Mon, 31 Mar 2025 22:50:00 +0000

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.

ISO 20417, 2nd DIS Breaking News from Tokyo Meeting 📣📣

leoeisner — Tue, 25 Mar 2025 20:38:12 +0000

ISO TC 210 WG2 met in Tokyo, Japan on 4 – 5 March 2025.

WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2^nd ed.

Thx to the hard work of our fearless Project Leader, doing a huge amount of prep work just prior to the WG meeting.
WG was able to review and resolve all the comments.
Next step will be to circulate for FDIS ballot ISO/FDIS 20417, 2^nd ed., that the NCs will vote on.

Changes proposed:

Add reference to transport and storage symbols for environmental conditions for packaging to distinguish between transport and storage environmental conditions.

Updated sub-cl 6.5.3 a) new sub items 2) & 3) with symbols for transport and storage – Special Section not included in LinkedIn Post
These symbols for transport is Symbol 3869 from ISO 14617-14:2004 (link goes to the ISO online browsing platform) and for storage is Symbol 2066 from ISO 14617-7:2002
This has been something I have been developing for more than a year with TC 210/ WG3 and also IEC 60601-1, 4^th ed., IEC TC 62/SC 62A/WG38 with a small team. At the Tokyo meeting TC210 / WG3 we have set up a task team to look at the proposed symbols for transport, storage and operation (operation was not included in ISO 20417 as no comment was provided). WG3 task team has not met yet so unable to share the proposed symbols from WG3 perspective at this time.

IEC TC 62/SC 62A/WG38, Fragment 2, (IEC 60601-1, 4th ed. – learn more about it) 62A/1630/CD was issued Dec 6 2024 and was closed for comments on Feb 28 2025. We are meeting in Arlington, Virginia at the AAMI offices to work on the comments March 30 – April 4, 2025. The two symbols above are part of the symbols that are in the CD and there are additional ones including one for operating IEC 60417‑6090:2012 and transient IEC 60417-5184:2002 environmental conditions, and indoor use IEC 60417-5957:2004. Some combination of the environmental conditions such as temperature, humdity, and atmospheric pressure will need to be combined as applicable to operation, storage and transport. Trainsient is a special condition. Please refer to the CD to understand the usage of the symbols.

Deleted 6.1.2 d) 1) (Change from “EC Rep” to “XX Rep”)

Align with update of ISO 15223-1:2021/A1:2025 published March 3, 2025 with “EC Rep” changed to “XX Rep” (5.1.2).
6.1.2 d) 1) previously stated: “When using symbol 5.1.2 from ISO 15223-1:—, the ‘EC’ may be replaced by the 2-letter or 3-letter country code given in ISO 3166-1.”

Added concept of “applicable policy”

New 3.3 definition.
Aligns with 1/2634/CDV of IEC 60050-880, 1^st ed, term 880-17-02) & about 20 additions in the normative text to “applicable policy” making those requirements based on what the authority having jurisdiction requires so more flexible.

Changed from “production control” to “production control identifier”

Make clearer the definitions of lot number, lot code, batch code, batch number, serial number, & other options noted in 5.9 of ISO 20417, 1^st ed. (will be 5.8 ISO 20417, 2^nd ed.)

The requirements related to commercial product name were deleted as they were duplicative of the catalogue number requirements.

Deleted 4 b)

The previous 4 b) roughly says: Normatively referenced edition of a standard in ISO 20417, ed., the manufacturer may substitute with a more current version provided by the manufacturer provided they can demonstrate the residual risk remains acceptable and is comparable to the residual risk that results from applying the normatively referenced document.
The normative referenced standards in the new draft FDIS are undated or dated. Undated references are required to be the most recent copy of the standard and the dated ones are required to be the dated version. ISO 15223-1 is the only dated normative referenced standard and references ISO 15223-1:2021 and ISO 15223-1:2021/AMD 1:2025 (ISO format requirements) in the draft FDIS.

HAS Consultant comments received late, added to collated comments, and resolved. JTC3 will prepare updated Annex Zs for addition to the FDIS

updated the normative references

Informative referenced standards (“should ” or “see standards” statement) were moved to the bibliography
Dropped ISO 16142-1 & -2 standards as both were withdrawn

Delete former informative Annexes D, F, G and H;

Annex D – Cross reference between the document and the requirements considered
Annex F – Reference to the essential principles (ISO 16142-1:2016 & ISO 16142-2:2017 – both withdrawn)
Annex G – Reference to the general safety and performance requirements for medical devices (Was previous corresponding list of GSPRs to the EU MDR list but will be replaced by Annex ZA^#)
Annex H – Reference to the general safety and performance requirements for IVD medical devices (Was previous corresponding list of GSPRs to the EU IVDR list but will be replaced by Annex ZB^#)
^# Annex ZA & ZB The FDIS will include Annex ZA & ZB prepared by JTC3 but not the final ISO publication.

Need Help?

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

10x Humanizing MedTech: Breaking The Mould For Conferences

leoeisner — Tue, 11 Feb 2025 06:39:03 +0000

Join us for the fifteenth 10x Medical Device Conference on May 7 to 8, 2025 – Hyatt Regency Newport Beach, CA

What’s 10x 2025 about you ask?

The focus is on building meaningful relationships and tackling real challenges
Move through key stages of the MedTech lifecycle. Each workshop station focuses on critical topics such as:
- Regulatory Pathways
- Cybersecurity
- Engineering
- Product Development
- Market Access
- Reimbursement
- Commercialization

Join experts Carrie Britton, Matthias Fink, Sean Smith, Jan Gates, Angelina Lisandrelli, Jose Bohorquez, and others experts for a journey through the MedTech lifecycle – from ideation to marketed product. Each workshop represents a stage of this journey, offering opportunities to collaborate, ask questions, and exchange expertise.

Thank you, Sean for including me on this impressive list of experts for 10x this year!

Looking forward to seeing you in Newport Beach, CA. – Seats are limited

Join us for this very personalized experience and Joe Hage‘s Ice Cream Social

MedTech Leading Voice 100 2025 Yearbook – Great Resource Tool!!

leoeisner — Sat, 25 Jan 2025 08:57:17 +0000

This is an amazing resource that MedTech Leading Voice has put together and is free to download.

‘This isn’t a “best of” list – it’s a guide to people worth following …

It’s a guide to 100 individuals worth following on LinkedIn—people who are sharing unique insights, actionable advice, and thought-provoking content.’ – Sean Smith, MedTech Leading Voice

So, what now?
Browse through to find leaders you want to follow – lots of different categories and interests
Explore their insights
Share your favorites in Leo Eisner’s LinkedIn Post comments for the MLV100

Now for my story of how I made it onto the MLV100 Yearbook list – Thank you Sean, Mike and many others in the MedTech community

My credo: “I like to support my clients and the MedTech industry in understanding standards, regulations, laws, and guidance. This is one of our cornerstones to support our clients from the beginning of the design and development process.”

My journey began, straight out of college, in 1985 at Underwriters Laboratories, where I gained experience in various product and component test standards, including UL and NFPA.

I joined TÜV SÜD in 1994, starting my medical career. I worked with medical electrical standards UL 601-1, UL 544, and IEC 60601-1, 2nd ed. and became an MDD auditor.

Moved into an industry role for a couple years and then decided to start up my consulting company in 1998 full time.

I have been fortunate to be involved in standards development over the past 20+ years to benefit my clients and industry. This helps me stay updated and assist my clients in product design and development.

My focus has been IEC 60601-1. I am one of the conveners for the 4th ed. of IEC 60601-1 which is under development currently. But I am also involved in a lot more standards than just IEC 60601-1. Check out my LinkedIn profile.

I have always been happy to share my knowledge via blog posts, articles, webinars, and podcasts.

It’s an honor to be included with this amazing listing of MedTech experts, Regulators, entrepreneurs, and influencers.

Thank you, Sean and MedTech Leading Voice, for including me on this impressive and very unique list. You’ve built a collaborative community that enhances skills and knowledge in the MedTech community!

Need Help?

The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

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

Leo Eisner, The60601Guy will be visiting London in October. You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct.

Meet me in London – I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁. I’d love to chat!

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

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

What Standards Apply to My Device? Podcast #383

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

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

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

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

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

Need help with 60601 series standards including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. His team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here to support your needs.

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

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