Just another WordPress site
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
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.
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.
Regulatory Update – January 2022 Index I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world