Jon Speer, founder and VP of QA/RA @ greenlight.guru (moderator of the webinar) and I, Leo the “IEC 60601-1 guy” Eisner, Principal Consultant of Eisner Safety Consultants, will be presenting a Webinar on the 15 Steps to Get IEC 60601-1 Approval on December 13, 2016 1PM ET/10AM PT. Sign-up now for the limited live seating of the free webinar.
Speed your time to market by following the step-by-step instructions that I will discuss in this free, 90 minute webinar, so you can obtain your product certification to IEC 60601-1 series of standards quicker.
I will 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.
Take Aways from this Webinar:
- The IEC 60601-1 standards series & 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?
- Understanding the importance of the Risk Management File and Essential Performance requirements.
- 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?
- What samples are needed for testing?
- Resources to help with this process and ways to reduce the paperwork off your backs. Get your free sample of Our Annual Standards Trends Report. Learn more about our Annual Standards Trends Report service.
If you want to get a prelude to this webinar listen to the podcast that discusses some of the Take Aways of this presentation.
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 Imaging 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.
About greenlight.guru
greenlight.guru is the only Quality Management Software built exclusively for the unique needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Visit their home page to learn more.
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 our services we offer.