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.

Watch Free Webinar IEC 60601 Amendments & CB Scheme

Watch Free Webinar IEC 60601 Amendments & CB Scheme

Learn from an ๐—ถ๐—ป๐˜€๐—ถ๐—ฑ๐—ฒ๐—ฟ ๐—ฐ๐—ผ๐—บ๐—บ๐—ถ๐˜๐˜๐—ฒ๐—ฒ ๐—บ๐—ฒ๐—บ๐—ฏ๐—ฒ๐—ฟ that wrote portions of ๐—œ๐—˜๐—– ๐Ÿฒ๐Ÿฌ๐Ÿฒ๐Ÿฌ๐Ÿญ-๐Ÿญ, ๐—ฒ๐—ฑ ๐Ÿฏ.๐Ÿฎ ๐—”๐—บ๐—ฒ๐—ป๐—ฑ๐—บ๐—ฒ๐—ป๐˜๐˜€ and is involved in the development of the Fourth Edition of IEC 60601-1. If you want to learn about these updates to the standard and the IEC 60601 Amendments Project – You’re in luck – Leonard (Leo) Eisner the “๐—œ๐—˜๐—– ๐Ÿฒ๐Ÿฌ๐Ÿฒ๐Ÿฌ๐Ÿญ ๐—š๐˜‚๐˜†” from Eisner Safety Consultants partnered with Holly Rossington of BSI to present the webinar “Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers”

Leo Eisner the “IEC 60601 Guy” co-presenter in BSI Webinar

Leo Eisner the “IEC 60601 Guy” co-presenter in BSI Webinar

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 be presenting on the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.

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

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

Last week, 29 Apr โ€“ 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.