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 15 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, web meetings, e-mail, & overnight delivery services.
Are you ready for changes coming for 60601-1, 3rd edition + Amendment 2 and 4th edition of IEC 60601-1?
We offer services that can help you stay up to date and ahead of the curve so you are prepared for these changes that are coming. Check out our Annual Standards Report and our Standards Reconnaissance Database as resources that can save your company time and money.