Home
Contact Information
Featured Articles
Client Services
Affiliates
Associates
References
Events
Web Links
Library
Job Postings

What's New - This page has recent revisions to the website.

If you missed any of Eisner Safety Consultants Presentations thru FX Conferences on IEC 60601-1, 3rd ed. and FDA 510(k)s you can purchase any of them now and get a $50.00 discount by using coupon code AF2009EIS.  When checking out place AF2009EIS in the box indentified as coupon code.  This discount is only applicable for these three products

IEC 60601-1, 3rd Edition Medical electrical equipment – Part 1: General requirements for basic safety and essential performance published December 2005 - Contact us for further information
To Purchase a copy of IEC 60601-1, 3rd Edition click on the web-link
To view a list of IEC 60601 series of standards available for purchase follow this web-link

ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, Modified) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance was published February 2006 - Contact us for further information
To Purchase a copy of ANSI/AAMI ES60601-1:2005 click on the web-link
To view a list of AAMI standards available for purchase follow this web-link

	Article authored by Leo Eisner, Dan Modi, Mike Schmidt and Frank O'Brien published in MD&DI: A New U.S. National Standard for Medical Devices -- September 2006
	Article authored by Leo Eisner, Charles Sidebottom, Harvey Rudolph, and Michael Schmidt in Journal of Medical Device Regulation: "IEC 60601-1 – The Third Edition" -- May 2006
Articles authored by Leo Eisner, Dan Modi and Bob Brown published in MD&DI, MEM, & CE:
	"Risk Management Implications of IEC 60601-1, 3rd Ed." -- January 2005 issue CE.		"A Regulatory Review of the EMC Standard for Medical Devices" -- January 2005 issue CE.
	"Safety Requirements: Understanding IEC 60601-1" -- Fall 2004 issue MEM.		"Leakage Current Standards Simplified" -- July 2004 issue MD&DI.
	"IEC 60601-1: Medical Device Marking and Labeling" -- May 2004 issue MD&DI.		"National Deviations to IEC 60601-1" --February 2004 issue MD&DI.
	"A Primer for IEC 60601-1" -- September 2003 issue MD&DI.

Company Profile

Eisner Safety Consultants  (ESC) is a network of experienced professionals which provides affordable, on-time product approvals via safety and regulatory agencies. The company  provides support to medical device, in-vitro diagnostic, and other high tech electronic device companies.  We provide assistance with U.S., Canadian, European, and other international regulations.  Specialties include preparing 510(k)s, product safety support to IEC 60601-1 series of standards, Quality Systems, CE Mark, FDA, Canadian Medical Device Regulations (CMDR), and training.  For further details please see our complete list of services.  All of our associates have more than 20 years of experience working in both international regulatory agencies and industry.  This way we can provide answers to the regulatory issues, while meeting your business needs.

We are headquartered in Portland, Oregon, but have associates located throughout the West Coast and the United States.  Our associates can come to your location, or in many cases provide support via phone, facsimile, e-mail, overnight delivery services, and the internet.

Contact Information