ISO – Eisner Safety Consultants

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 – through tougher design reviews, deeper questions during pre-submission interactions, 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 regulatory expectations intersect in real programs.

This is 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.

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

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.

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.

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

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.

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

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.

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

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.

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