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

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

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,

IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed.,

How to ID Applicable Standards – Combinate Podcast

How to ID Applicable Standards – Combinate Podcast

Join me, Leonard (Leo) Eisner, the “IEC 60601 Guy”,

in a conversation with Subhi Saadeh of Combinate Podcast

as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148

Welcome 3 Global Experts to the Eisner Safety Consultants Team

Welcome 3 Global Experts to the Eisner Safety Consultants Team

We are thrilled to announce three incredibly talented individuals joining the Eisner Safety Consultants Team to support your needs.

Beat Keller’s expertise comprises the IEC 60601 series, software, and regulatory/quality. In the regulatory/quality area his focus is on EU MDR, Swiss MedDO and UK MDR.

Lisa Donlon’s expertise encompasses device regulatory/submissions and quality. Her focus is on EU MDR, clinical support, and the U.S.

Dan Modi’s expertise spans the IEC 60601 Series, EMC, design quality, device submissions/regulatory – EU MDR, U.S., India, China, Brazil, Japan and more.

We have strengthened our team to support your needs so please feel free to schedule a meeting to discuss your needs or contact us.

Standards: Explosion and Challenges Maintaining/Updating

Standards: Explosion and Challenges Maintaining/Updating

Standards: Explosion and Challenges Maintaining/Updating

 My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.