Medical Electrical Standards are constantly being changed and evolving and the amount of changes seems to be accelerating. All too often I hear 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.

Take Aways from this Webinar:

• 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

If you want to learn more about the IEC 60601-1 certification process you can read an article on the greenlight.guru blog of a presentation I gave awhile back on this process.

ABOUT THE PRESENTER:

This webinar is being lead by me (Leo Eisner), “The 60601-1 Guy”, founder and principal consultant at Eisner Safety Consultants and moderated by Jon Speer of greenlight guru.

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.

Eisner Safety Consultants has helped countless clients thru the Product Safety and Regulatory maze over the 20 year history of the company. Leo 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.

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.

We have 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!

Standards are absolutely critical when you are developing a medical device.

You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to incorporate them as part of your design and development process at the beginning rather at the end.

Listen Now:

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“Your indications for intended use [of your device] are directly impacted by the markets where you plan for your product to be used.” –Jon Speer

In the Podcast Leo & Jon discuss:

• How Leo’s career in standards began
• Why standards are important
• Why should I care about standards regarding my medical device
• Standard IEC-60601
• Standards Reconnaissance Database
• Benefits of standards
• Updates to standards
• Classifying your product, drafting a test plan, checking against standards

“The most important reason you should care about standards is because of your regulatory submissions and your design process.” – Leo Eisner

A vital recommendation I tell my clients: When it comes to standards 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 in several ways.  We can provide you with a tailored list of standards based on your product line(s), or you can sign up for our specially designed Standards Reconnaissance Database to help you navigate the standards that apply to you.

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.

We strive at Eisner Safety Consultants (ESC) to provide the best services for our clients and we have found one that is ideal for many of our small to mid size medical device companies we work with.  greenlight.guru produces an electronic Quality Management System (eQMS) solution built exclusively for medical device companies that is:

• Simple to use,
• integrated product development activities with quality processes,
• is hosted in a secure cloud environment,
• is easy to deploy,
• your team can be spread out all over the world & be able to work on the same documents without any lapse or issues of communication,
• provides easy to use project management tools,
• consolidates your documents into one system,
• helps coordinate your design process into a visual based system that is easy to follow,
• helps fulfill the requirements of ISO 13485, 21 CFR Part 820, and ISO 14971 (& EN 14971),
• has an easy to use document control process,
• and so much more,

This solution will help you ensure compliance, reduce risk and improve team collaboration from the idea stage all the way through post market commercialization. With greenlight.guru’s powerful, easy to use eQMS solution, and Eisner Safety Consultants expertise we will help medical device companies navigate the ever shifting regulatory, quality systems, and product safety environments, enabling them to bring higher quality life changing devices to market, faster – which, after all, is our mission.

To find out more about greenlight.guru please contact Leo Eisner at Leo@EisnerSafety.com or call us at 503-244-6151 or go to our Partners page. We would be happy to discuss the product with you and set you up for a demonstration of the greenlight.guru eQMS solution so you can test drive it to see if it is the right fit for your company.