Eisner Safety Consultants: Qmed Qualified Supplier

IEC 60601-1 Basics Workshop – Las Vegas – 20 Mar 2018

Las Vegas Workshop















Event Time:             Cost (Per/Person):          Location:
March 20, 2018          $200.00/person              Embassy Suites –  Las Vegas
Tuesday                     (Pay on PayPal)              4315 Swenson Street
1:00 – 5:00PM                                                    Las Vegas, Nevada 89119

Speed your time to market by learning some of the basics of IEC 60601-1 and following step-by-step instructions that will be discussed by the “60601 Guy”, Leo Eisner, which will help you obtain your product certification to IEC 60601-1 series of standards quicker.

This workshop is a great intro for any RA/QA person that wants to learn about IEC 60601-1, the series of standards, how to prepare for a product certification project and much more.

If you are joining for the 510(k) Workshop hosted by Rob Packard of Medical Device Academy this is a great opportunity for you to join the “IEC 60601 Guy”.

Special Features of Workshop:

  • This will be a small group workshop so help decide the topics the “60601 Guy” will present.  After you register Leo will contact you to get your top 2 or 3 topics from the listing below.
  • Spend up to 1/2 hour private conversation with the “60601 Guy” before or after the Workshop to discuss your product questions, specific 60601 questions, or to learn more about Eisner Safety Consultants and what services we can provide to your organization.  Leo, will be available for these individual private meetings:
    • Tues, March 20 10:00 AM – Noon or join him for lunch
    • Tues, March 20, 5:30 – 7:00PM or join him for dinner
    • Wed, March 21, during breakfast, lunch or breaks at the 510(k) Workshop
    • Thur, March 22, during breakfast, lunch or breaks at the 510(k) Workshop

This workshop will help you with a better understanding of some of the basics of the standard and series of standards. As an option, your choice, the workshop will help you formulate a standards strategy for overall regulatory pathway strategy for your medical electrical device or system.

You will be walked through the basic concepts of IEC 60601-1 and 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 “60601-1 Guy”, Leo Eisner 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.

Select which topics you want to focus on:

  • The structure of the IEC 60601-1 standards series & which to 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 how spacings work and how they connect with the isolation requirements.
  • Understanding the importance of the Risk Management File and Essential Performance requirements.
  • Learn about the basic tenet of the standard – 2 levels of protection
  • Summary of tests for IEC 60601-1 & why is leakage current so important and what .
  • Basics of understanding of marking and labeling requirements in the standard & where are they located in the standard.
  • Know your critical components.
  • A sampling of countries and what version of national IEC 60601-1 standards apply
  • A strategy for when to run pre-tests and what’s not worth testing?
  • What samples are needed for testing?
  • Resources to help with this process.
  • Other topics related to IEC 60601-1

About the presenter:

This workshop is being lead by Leo “The 60601-1 Guy” Eisner, founder and principal consultant at Eisner Safety Consultants.

Leo is a licensed professional engineer in safety engineering, a Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards), standards developer for IEC 60601 series 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.

Contact us with questions about this Workshop: Leo at EisnerSafety dot com or 503-244-6151