Software – Page 4 – Eisner Safety Consultants

Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London

Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and More with Leo Eisner and Ian Sealey

What’s on the menu🍰?

Where are we headed with 4th Ed.?
Structure changes;
Project timeline: and
Critical documents

Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants will be your guide

What to do in the meantime?
Select applicable and normative standards for testing; and
How to set up a solid future-proof test plan

Ian Sealey of Vertexian will explain it

Clayton Hotel Chiswick
Arrive 5:15 PM
Starts 5:30 PM sharp
Ends 8:45 PM

Networking and meet for drinks afterwards

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

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.

IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization

Last week, 29 Apr – 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

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.