leoeisner – Page 10 – Eisner Safety Consultants

IEC 60601 Amendments Updates Are Coming – Are You Ready?

Join us on Wednesday, July 29, 9 AM Pacific (Noon Eastern), for a live Zoom conversation with Leo Eisner the “IEC 60601 Guy” of Eisner Safety Consultants and Rob Packard of Medical Device Academy. Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation. See the infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.

How to Access EU Harmonized Standards List for Medical Based Directives (Non-HTML)

Just found out that the HTML listing of the Harmonized Standards listings are not available anymore. Not that they have been up to date of late anyway but still I refer to them a lot. So, when you search for

What Do You Need to Know About Remote Audits?

Are you falling behind on your internal audit or supplier audit plans due to COVID-19, other emergency situations, sickness, travel restrictions, time constraints? It really doesn’t matter the reason why you can rely on external resources to support your audits

InCompliance Annual Guide Articles

As a Senior Contributor to InCompliance, many years I am asked to update my articles to be placed in the Annual Guide but rarely do 2 of my articles show up in the Guide in a year. This year 2

MDCG March ’20 Meeting – Industry & Notified Bodies Provide Feedback

The Medical Device Coordination Group (MDCG) is meeting on March 11 & 12th to hold a series of meetings. Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR