Eisner Safety Consultants
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 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, the United States and Canada. Our associates can come to your location, or in many cases provide support via phone, facsimile, e-mail, overnight delivery services, and the internet.
Are you ready for 60601-1, 3rd edition? We offer Gap Analysis Services for 60601-1, 3rd ed.
- IEC 60601-1, 3rd Edition Medical electrical equipment – Published December 2005
- Purchase a copy of IEC 60601-1, 3rd Edition
- View IEC 60601 series of standards available for purchase
United States National Version with US Deviations
- ANSI/AAMI ES60601-1:2005 Medical electrical equipment – Published February 2006
- Purchase a copy of ANSI/AAMI ES60601-1:2005
- View AAMI standards available for purchase
Canadian National Version with Canadian Deviations
- CAN/CSA C22.2 NO. 60601-1-08 Medical electrical equipment – Published February 2008
- Purchase a copy of CAN/CSA C22.2 NO. 60601-1-08
- View CSA standards available for purchase
European Version (from British Standards Institute)
- BS EN 60601-1 Medical electrical equipment – Published November 2006
- Purchase a copy of BS EN 60601-1
- View BS EN standards available for purchase