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

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. 

Watch the webinar

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

Hosted by

Presenter: Leo Eisner

Principal Consultant, Eisner Safety Consultants

Moderator: Nick Tippmann

VP of Marketing, Greenlight Guru


About Eisner Safety Consulting

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.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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