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FREE ON-DEMAND WEBINAR

15 Steps to Get Approval to IEC 60601-1

Watch the Free On-Demand Webinar

 

Speed your time to market by following the step-by-step instructions, Leo the “IEC 60601-1 expert”, will discuss in this free, 90 minute webinar so you can obtain your product certification to IEC 60601-1 series of standards quicker.

Leo is going to walk you through the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.

Learn from the expert the mistakes others have made that have slowed down their certification process (and how you can avoid them).

Take proactive steps so your product doesn’t need to get redesigned after testing starts.
 

Specifically, you will learn:
  • The scope of IEC 60601-1 standards & if they apply to your product.
  • What you need to know to classify your products to the IEC 60601-1 series.
  • What is an isolation diagram and how does that help me with my design?
  • Determine the applicable tests for your device.
  • What are the marking and labeling requirements for the device?
  • Know your critical components.
  • What pre-tests to run and what’s not worth testing?
  • Resources to help with this process and ways to reduce the paperwork off your backs.

*Note: Limited live seats available.


 
About the presenter:

This webinar is being lead by Leonard "The 60601-1 Guy" Eisner, founder and principal consultant at Eisner Safety Consultants.

Leo is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device EU Directives.

Leo has helped countless clients thru the Product Safety and Regulatory maze over his career. He has 30 years experience in product safety. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service. Prior to that Leo worked in a cross section of groups at U.L. for 9 years.


Presenter

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Leo Eisner
Principal Consultant
Eisner Safety Consultants

Moderator

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Jon Speer
Founder & VP QA/RA
greenlight.guru

greenight.guru

About greenlight.guru

greenlight.guru is the only Quality Management Software built exclusively for the unquie needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Visit our home page to learn more.


 

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About Eisner Safety Consultants

Eisner Safety Consultants provides affordable, on-time product approvals via safety & regulatory agencies to medical device companies. We provide assistance with U.S., Canadian, European, & other international regulations. Click here to learn more about all the services they offer.


 

 

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