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What You Need to Know About Medical Electrical Standards Updates (And How They Affect Your Regulatory Strategy)

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Medical Electrical Standards are constantly being updating. 

All too often our presenter Leo Eisner, “The IEC 60601-1 Guy” and principal consultant at Eisner Safety Consultants, hears clients complain that they didn't know about a standard until way too late in the process and have had to redesign their product to meet regulatory requirements. 

So how do you stay up-to-date on all these changes? Are you considering the implication of these standards when putting together your regulatory strategy? Do you know what standards are coming down the line and how they may impact your product design? Are these standards harmonized in different markets? Does your test lab always know what versions of standards you need to test too?

If you have a medical electrical device or a software as a medical device and your answer to any one or more of these questions is NO then this free 90 minute webinar is for you. 


specifically, You Will learn:

  • What medical electrical and related standards are being updated now and how they interact with each other.
  • What is the schedule for the IEC 60601 Amendment Projects and what other standards (i.e. ISO 14971, IEC 62366-1, IEC 62304) will impact the project?
  • Overview of the recently released Wireless Coexistence Standards for US.
  • Why you may need to redesign your product to meet the EMC Standard IEC 60601-1-2:2014 (4th Ed.).
  • How does testing under the CB Scheme impact your testing and regulatory strategies? 
  • Resources to keep track of standards from both a regulatory and standards development perspective.

Who should attend?

  • Medical Device Executives
  • QA/RA Professionals at all levels

  • Compliance Engineers

  • Quality Engineers

  • Design Engineers

  • Project Management Engineers

  • Senior Staff involved in management reviews per ISO 13485 for the standards update section


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.



Leo Eisner
Principal Consultant
Eisner Safety Consultants




Nick Tippmann
Director of Marketing
Greenlight Guru


About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our home page to learn more.



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.