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Rapid Growth in Home Use of Medical Devices Requires New Standards

Read the recent IEC e-tech magazine article (in Oct 2016 e-tech) titled ‘Rapid growth in home use of medical devices requires new standards‘.  It discusses both medical and non-medical home use devices and where standards development is going.  Also, it discusses wellness devices which can be a medical device or a non-medical device depending on its intended use, in some countries.

‘IEC work underpins fast growing support for home use of health and wellness devices’ – IEC e-tech article quote

Dexcom G5 Mobile is a compact continuous glucose monitoring (CGM) system that can provide accurate, real-time glucose readings every five minutes for people with type 1 or type 2 diabetes on mobile devices (Photo: Dexcom, Inc.)

Dexcom G5 Mobile is a compact continuous glucose monitoring (CGM) system that can provide accurate, real-time glucose readings every five minutes for people with type 1 or type 2 diabetes on mobile devices (Photo: Dexcom, Inc.)

IEC has published the above article that I originally wrote back in August 2016 (The above IEC article is written with a slightly different spin on it) for

InCompliance Aug 2016 Cover Pg

photo courtesy of In Compliance Magazine, Aug 2016

InCompliance Magazine
titled “Home Use Medical and Wellness Devices”.
Both articles are worth a read as you will learn different information from each one.

I hope you enjoy the two articles and if there is anything I can answer please contact me at either Leo at EsnerSafety dot com or 503-244-6151.

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15 Steps to Get IEC 60601-1 Approval – Webinar

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.15 Steps to Get IEC 60601-1 Approval 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.

Copy of Copy of greenight.guru

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.

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Tips for Success When It Comes to IEC 60601-1 – Podcast

Jon Speer, founder and VP of QA/RA @ greenlight.guru and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a dynamic & interesting conversation that we are sharing as a podcast with you on tips for success when it comes to IEC 60601-1.

iec_60601-1_leo_eisner_podcastEisner Safety Consultants has teamed up with greenlight.guru, a specialized electronic Quality Management System (eQMS) platform specifically designed for small to mid-size Medical Device companies. greenlight.guru will reduce your quality management system overhead, a web based system, which is easy and practical to use, will minimize your paper trail, and consequently your need for excessive consultant hours allowing you to focus on your product and getting to market. greenlight.guru and Eisner Safety Consultants are both well equipped with our specialized expertise and know how to get your device to market, and more importantly – STAY in market!

IEC 60601-1 is the gold standard for electrical medical devices around the world. IEC 60601 is a challenge for many companies that are developing electronic medical devices.  It’s wise to have a guide to help you understand and work through the process, and in this podcast I discuss with Jon Speer some guidance you can use.

You need to understand why this standard series is important when developing your electrical medical products for your regulatory submissions. You need to know what they are (join our webinar on the 15 Steps to Get IEC 60601-1 Approval on Dec 13, 2016 to get more details) and understanding how to incorporate them as part of your design and development process at the beginning rather at the end of the process.

Listen Now:

In the Podcast Leo & Jon discuss:

● What makes the 60601 process different from the other regulatory compliance processes.

● Some of the details on the differences between creating a device for the ER vs. for home use and for use in other types of facilities.

● Tips on preparing for success when creating a timeline for getting through the 60601 process, as well as some of the steps involved.

● Differences between different types of safety labs and the criteria that’s vital to understand to help you make the right choice.

● What to do early in the process of product design and development to be sure you’re on the right track long before you get to the production phase.

● Why it’s vital to keep the 60601 standard in mind, not only when it comes to meeting the standards, but also when it comes to patient safety.

● The Annual Standards Trend Reports (click to get a sample report now & our new pricing) and how you can benefit your company and save money and time.

Give yourself a buffer. There will be bumps in the road… guaranteed.”  “Some labs know medical very well, and there are a lot that don’t.” – Leo Eisner

A recommendation I tell my clients: When it comes to developing products to the IEC 60601 series of standards is that you need to know your product well enough to determine what standards apply early in the development process – from there you’ll know how much preparation and testing it will take.  If this is something you don’t have the expertise or the bandwidth for we can do it for you.  One tool I recommend for my clients is we can provide you with our Annual Standards Trend Reports (click for a sample report & our new pricing) so you are strategically positioned for the changes that are coming, the new standards in development and for the recently released standards you didn’t even know exist.  View a sample of our Annual Standards Trend Reports & our new pricing.  The Annual Standards Trend Reports can to help you navigate the standards that apply to you and save you a lot of money and time.

About The Global Medical Device Podcast:










The Global Medical Device Podcast powered by greenlight.guru is where today’s brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world’s leading medical device experts and companies.

Like this episode? Subscribe today on iTunes, Sticher or SoundCloud.

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Save $20K or more with ESC’s Annual Standards Trends Reports

Eisner Safety Consultants’ Annual Standards Trend Reports can save you time and money by:

  • Reducing the amount of time needed to put your list of Current Standards together for your Quality System
  • Having an early warning system in place to be able to strategically plan your product development (in some cases you may need to redesign & lead time is important)
  • Reducing your company’s time needed to monitor the standards development that are important to your products
  • Reducing your overhead for Standards Committee participation as you will leverage ESC’s expertise and time
    • You can avoid paying for:
      • costly committee membership fees,
      • travel expenses & employee time away from the office to be part of these committee meetings,
      • employee time to work on committee commitments (an expectation of membership), and
      • research time putting these reports together.

Easily save $20,000 or more/year (Some users have said they have saved over $100,000 with these valuable reports). Avoid the last minute redesign because you weren’t up to date on the proper standards. Would you rather spend the $20,000.00 or more every year or get these reports (click for a free sample of the 2016 report) at even lower prices than last year’s (reduced 40% or more)!! 

March 2017 Annual Standards Trends Report (ASTR) Options:

Only $1,997.00 for the:

March 2017 Medical Electrical Equipment & Systems (MEES) ASTR or
March 2017 Home Use MEES ASTR

Only $2,997.00 for the:

Bundle pricing of both the March 2017 MEES & Home Use MEES ASTRs

March 2016* & 2017 Annual Standards Trends Reports (ASTRs) Options:

Only $2,397.00 for the:

March 2016* & 2017 Medical Electrical Equipment & Systems (MEES) ASTRs or
March 2016* & 2017 Home Use MEES ASTRsform>

Only $3,697.00 for the:

Bundle pricing for all 4 Reports – March 2016* & 2017 of both MEES & Home Use MEES ASTRs

March 2016* Annual Standards Trends Report (ASTR) Options:

Only $697.00 for the:

March 2016* MEES ASTR or
March 2016* Home Use MEES ASTR

Only $1,197 for the

Bundle pricing for both the March 2016* MEES & Home Use MEES ASTRs

* = The March 2016 ASTRs are issued as of March 2016 with no updates.

As a side note we have closed our Standards Reconnaissance Database as of end of July 21, 2016 and decided to focus only on the Eisner Safety Consultants’ Annual Standards Trends Reports.

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Home Use Medical & Wellness Devices Article by Leo Eisner

InCompliance Aug 2016 Cover Pg

photo courtesy of In Compliance Magazine, August 2016

Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an IV bag) after a knee joint infection that I had to have emergent surgery & stay in the hospital for 2 days in Early June 2016.  I was out of work for about a month and so I got a close birds eye view of why the medical device and wellness device markets are exploding.  This explosion of interest comes from several factors including the “Super aging” of societies around the globe, Internet of Things (IoT), the portability of devices, the growth of wearable technologies and other factors discussed in the article.

There is a huge need to support those at home that are sick, injured, has an acute issue or chronic illness that want a comfortable life and would rather stay at home then be in a sterile hospital or other clinical setting any longer than they have too.  I know I was ready to get home after 2 days in the hospital, even though I had to rest at home, I was much more comfortable at home than in the hospital setting.  So, now I can appreciate how important it is to have these medical and wellness devices evaluated for the proper environment and proper standard(s) and to meet national regulations.   One of the issues that is important to this conversation is the blurry line between home use medical devices and wellness devices.  FDA has written guidances for both Home Use Medical Devices and Wellness Devices to clarify from their perspective.  There, also is a newer IEC System Committee called Active Assistive Living (SyC AAL) that is looking at the gaps in standards and other IEC technical documents for home use medical devices and non-medical devices (Some being wellness devices).  The article goes into detail on this SyC AAL and also looks at the medical electrical device standards focused around Home Use Medical Electrical Devices.

Enjoy the article and if you have interest in or need help with the IEC 60601-1 series, home use medical electrical devices or the SyC AAL please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants.