What’s on the menu?

Where are we headed with 4th Ed.?
Structure changes;
Project timeline: and
Critical documents

Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants will be your guide

What to do in the meantime?
Select applicable and normative standards for testing; and
How to set up a solid future-proof test plan

Ian Sealey of Vertexian will explain it

When, Where, How:

7 October 2024

Clayton Hotel Chiswick
Arrive 5:00 PM
Starts 5:30 PM
Ends 8:45 PM

Networking and meet for drinks afterwards

Register by either using our Contact form or send Leo a LinkedIn message via his profile.

If you would like to meet with Leo during the week of 7 Oct in London please contact him to schedule this rare opportunity.

Presenters Background:

Leo is the founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry (from SME’s to Fortune 500’s) with product safety compliance & regulatory support focused on:

• design for compliance to IEC 60601 series of standards;
• design reviews against applicable requirements;
• identification of applicable standards, laws, regulations, directives and guidances;
• labeling reviews;
• support with test labs;
• training

Leo’s leadership and commitment in the standards development process runs deep and over many years including his involvement in numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years. 
His IEC 60601-1, 4^th edition involvement:

• Co-Convener of IEC/TC 62/SC 62A/WG39 – User interface aspects
• Advisory group member of IEC/TC 62/SC 62A/AG 50 – IEC 60601-1 Ed. 4.0 editing & leadership team
• Committee member IEC/SC 62A/WG37 – General requirements

To see a more detailed list go to Leo’s LinkedIn Profile.

Ian Sealey is the founder of Vertexian and is a medical device regulatory and quality consultant, with over 25 years’ experience. Vertexian provides the medtech industry with support in the following areas:

• electromedical devices;
• risk management;
• pre-compliance testing;
• training;
• UKCA marking; and
• manufacture of IEC test equipment

He was Assistant Secretary to the Board of the Department of Health (DH), a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA), and a principal Medical Engineer in the National Health Service (NHS). He is a director of a health-related charity and a visiting university lecturer.

Need help with 60601 series standards including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. He team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here to support your needs.

We work with many test labs for Medical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments of 2022 (MDUFA V). The ASCA program’s goals are to:

• streamline the conformity assessment in medical device submissions,
• enhance the FDA’s confidence in test methods and results,
• decrease the need for additional information related to conformance with a standard,
• promote consistency, predictability, and efficiency in medical device review,
• serve as a least burdensome approach to conformity assessment

The ASCA program’s final guidance documents, issued in 2020, set the current framework for the program:

• Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Final Guidance (Program Guidance)
• Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the ASCA Pilot Program – Final Guidance (Standards Specific Guidance)
• Biocompatibility Testing of Medical Devices – Standards Specific Information for the ASCA Pilot Program – Final Guidance (Standards Specific Guidance)

The FDA grants ASCA accreditation to test labs that meet the requirements of the program. The ASCA test labs are authorized to conduct testing and the output from the lab is a summary report that the manufacturer submits to the FDA (more to come). Once the FDA approves an ASCA test lab the FDA identifies the scope of recognized consensus standards that the lab is able to test too (they are able to expand that list over time & the FDA may suspend any and all of the scope of the lab, if appropriate), the name & address of the lab and the ASCA contact on the ASCA test lab list. If the lab is suspended there seems to be a note in the current scope, there is no separate search feature on the db for active and suspended labs. I just sent in a request to the standards and conformity assessment (S-CAP) group that is in charge of this db to ask if they can make this more user friendly.

FDA has added standards to the list of approved standards beyond what is noted in both Standards Specific Final Guidance documents and plans to continue to add recognized consensus standards to the list/db. You can search the list of recognized consensus standards db but make sure you click the check box next to “Included in ASCA?” to view the list of standards that are included in the ASCA program. When you get to the link for a specific standard make sure you review the standard and see if any limitations on the standard if a partial or full recognition and also if there are any limits from the ASCA program perspective so you know what to expect. Then you need to make sure the test lab you are planning to use has the applicable standards in scope, that apply to the product that you want to test for your submission to the FDA.

You’ve chosen a test lab and gotten a test quote including the ASCA costs. Now you need to get the testing done but please make sure before you submit to the FDA you don’t have any comments on the summary report from the ASCA lab that aren’t positive towards the approval. If there are any issues you want to resolve them before a final report is issued from the test lab to the manufacturer. The manufacturer provides the summary report as part of the premarket submission, not the test lab. You want a clean summary report going to the FDA, as the FDA relies on the ASCA’s test lab summary report instead of the full test report that has been submitted in the past.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA, the ASCA program or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List # 060. A reminder that Recognized Consensus standards are considered voluntary by the FDA for premarket submissions but they are what the majority of manufacturers use to facilitate & streamline the premarket process.

Relevant FDA Guidance and/or Supportive Publications*

US national differences:

1. (Recognition Number: 19-46) ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]

2. Attachment Form No.: US_ND_IEC60601_1U ATTACHMENT TO TEST REPORT IEC 60601-1: US NATIONAL DIFFERENCES – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
(https://documents.iecee.org/ords/f?p=702:558:::::P558_DOCUMENT_FILE_ID:2955038)

Note from Leo: This is a US National Difference Test Report Form issued by the CB Scheme for CB scheme reports.

You have 3 options
1 expires after December 17, 2023
The first 2 are acceptable now & going forward.

1) Use IEC 60601-1 Edition 3.2 (Recognition # 19-49) from now onward making sure to use References #1 AND #2.
Note: This first option is the best of the three. Test to the IEC standard as that way you can prepare your product for the US domestic and international markets at the same time. If you pass the testing you’ll meet most if not all requirements and then you can deal with the few US National Differences by applying the US National Differences which are also in item 2) of this list anyway. This is less restrictive for your product than if you test your product to the US version of the standard (ANSI AAMI – Item 2 of this list) and then try to go to the international market which most countries will require IEC testing anyway.

2) Use ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Recognition Number: 19-46) from now onward.
Note: This SIS is an older Recognized Consensus Standard but by inference, one would be wise to make sure that you also get the US National Difference Test Report mentioned above for the IEC 60601-1, ed. 3.2 which is based on the ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Recognition Number: 19-46)

3) During the transition period FDA will accept a declaration of conformity in support of premarket submissions to the older ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (Recognition Number: 19-4) but it will be superseded by recognition of ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) [Including Amendment 2 (2021)] (Recognition Number: 19-46) after December 17, 2023.
Note: The SIS says that Recognition Number: 19-4 (ANSI/AAMI ES60601-1, edition 3.1) by Recognition Number: 19-46 (ANSI/AAMI ES60601-1, edition 3.2) but if you are smart I would switch to Recognition Number 19-49 (IEC 60601-1, edition 3.2). FDA should accept this Recognized Consensus standard for your premarket submission as long as your submission includes the US national differences References #1 & #2.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

The FDA on May 30, 2022, same day as when the recent AAMI 60601 Amendments were Recognized, added the Interpretation Sheet 1 (ISH1) – Amendment 1 – on Essential Performance (Clause 4.3) and Single Fault Condition (Clause 4.7) based on IEC 60601-1:2005+A1:2012 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance to:
FDA Recognition # 19-46 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] and
FDA Recognition # 19-4 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).

ISH1 was added to both FDA Recognitions # 19-46 & 19-4 as a “Relevant FDA Guidance and/or Supportive Publications” not as an independent Recognized Consensus Standard.
The ISH1 was Issued 2021-03 by IEC. One reason why FDA probably didn’t include the ISH1 as a Recognized Consensus Standard is because it isn’t an ANSI and AAMI approved standard. A blog post on the ISH1 when it was issued can be viewed here.

The FDA has been reviewing Essential Performance (EP) during submission for many years, since the publication of the 3rd edition of IEC 60601-1:2005 and their Recognition of ANSI AAMI ES60601-1:2005. It was even discussed during the expert panel, May 2018, at the ASCA Workshop, which I was the expert on EP on the panel. So, expect that FDA will review your submission for EP both for the safety and the EMC side of your testing.

Questions you need to consider early in the product development:
* have you identified the clinical functions of your device that are EP,
* have you started your EP analysis,
* has the EP analysis been fully connected with your Risk Management File,
* have you written your EP so it is capable of being tested for the safety and EMC which will be tested differently,
* and so much more…

One of the next steps out of the generation of the ISH1, as noted in the blog post on ISH1, was the formation of the Project Team PT 62A-1 with a goal to generate a technical report IEC TR 60601-4-6 as a guidance document on Essential Performance. PT 62A-1 has been meeting since February of 2022 and been trying to work on figuring out how we want to provide guidance to manufacturers, test houses and regulators on Essential Performance and Faults related to EP. The main reason for this is that we have seen there is so much confusion on this subject by some manufacturers, test houses and regulators and we want to provide a document that will provide a consistent guidance on the concept of Essential Performance and Fault Safety related to EP.

Need help with Essential Performance, 60601 series standards (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

The FDA in a little over a month on 30 May 2022 (that is swift) has updated the Recognized Consensus database for the AAMI 60601 Amendmended Standards that are referenced in my previous post of May 13, 2022. The AAMI standards were published in late March 2022.

Not each Recognition was updated in the same way. Let me explain:

FDA Recognition # 19-46 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] – the ANSI AAMI ES60601-1 AMD2:2021 is identical to Amendment 2:2020 of IEC 60601-1:2005 (post corrected 13 June)

FDA Recognition # 19-47 ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] – the ANSI AAMI HA60601-1-11 AMD1:2021 is identical to AMD1:2020 of IEC 60601-1-11:2015 (post corrected 13 June)

FDA Recognition # 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] –  the ANSI AAMI IEC 60601-1-2:2014 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-2:2014

FDA Recognition # 5-131 ANSI AAMI IEC 60601-1-8:2006 and A1:20012 [including AMD2:2021] – the ANSI AAMI IEC 60601-1-8:2006 and A1:20012 including AMD2:2021 is identical to Amendment 2:2020 of IEC 60601-1-8:2006

FDA Recognition # 19-39 ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] –  the ANSI AAMI IEC 60601-1-12:2016 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-12:2014

Need Help?

Need help with 60601 standards (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

 Leo Eisner,

Topic:  Why Your Regulatory Strategy Can’t Ignore Medical Electrical Standards & Guidances

Track:  MD&M West: Regulatory & Quality Update

• The IEC 60601 series structure – why do all those dashes matter?
• An analysis of the medical electrical and related standards that have been recently updated or are in development, and how these standards interact with each other
• IEC 60601-1 and its collaterals (IEC 60601-1-XX standards) are going thru another set of changes – what are some of the impacts?
• What are the plans for aligning the particular standards (IEC 60601-2-XX & IEC/ISO 80601-2-XX) with the general (IEC 60601-1) and collateral standards in the 60601 series?
• Related standards that are in the process of change: ISO 14971, IEC 62366-1, and IEC 62304
• Standards and guidances inputs to your regulatory strategy (and product development plans) that need to be relayed to your regulatory, design and product development team members

Join in on the conversation thru LinkedIn

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.

Leo Eisner, the “IEC 60601 Guy” & Principal Consultant, of Eisner Safety Consultants attended several IEC SC 62A Maintenance Team (MT 28 & MT 30) and Working Group (WG14) meetings from March 22 – March 31, 2017 in Oslo, Norway and London, United Kingdom to start the work of reviewing the items agreed on (in Frankfurt Oct 2016) for IEC 60601-1, 3rd ed. + Amendment 2 (or ed. 3.2) for development and comment.

A2 of IEC 60601-1 & its’ related collateral standards are anticipated to be published by the end of 2019.  In only 2+ short years from now!!!!  Will you be ready?  We are offering a web special til the end of March May 2017 on our Annual Standards Trends Reports.  See more below.

A2 changes & collaterals changes may include any of the following:

• safety gaps needing corrections,
• known problems for regulatory bodies,
•  inconsistencies within the standard,
• technical errors, and
• updates of standard references.

The above was the criteria for the ‘Short List’ vote on which items were agreed to in Frankfurt (Oct ’16) for A2 for IEC 60601-1 and it’s collateral standards.

Also, you need to be aware that the items that didn’t make it to the ‘short list’ are slated to be worked on for the 4th edition of IEC 60601-1 (the ‘long list’) which is scheduled to be published in 2024.  This will be a much more significant set of changes including potentially restructuring the standard and maybe even making the whole series a database standard.

Are you ready for changes coming for 60601-1, 3rd edition + Amendment 2 and 4th edition of IEC 60601-1?

We can help you stay up to date and ahead of the curve so you are prepared for these changes that are coming.  Check out our Annual Standards Trends Report as a fantastic resource that can save your company significant time and money (upwards of $100,000+).

To provide you an opportunity to receive the Eisner Safety Consultants Annual Standards Trends Reports for a significant discount of this year’s copy of these reports (publication between Late May to June 2017) we are offering a web special til the end of March May 2017 to give you the opportunity to learn from Leo about the Amendment 2 meetings in Oslo, Norway and London, U.K. The reports will include more details where these Amendment 2 changes are at and what these changes are.  If you want to stay ahead of your competitors, and save on the cost of standards committee membership fees, save on travel expenses, save time instead of sitting in these meetings, and getting the benefit of staying up to date on medical electrical equipment & systems (MEE&S) standards and home use MEE&S standard consider this amazing deal:

Eisner Safety Consultants

Annual Standards Trends Reports on MEE&S &

Home Use MEE&S Options

Get This Year’s Report(s): May/June 2017 Annual Standards Trends Report (ASTR) Options:

Normally priced at $1,997.00 Web Special $1,597.00 for the:

May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTR OR

May/June 2017 Home Use MEE&S ASTR

Normally priced at $2,997.00 Web Special $2,497.00 for the:

Bundle pricing of both the May/June 2017 MEES & Home Use MEE&S ASTRs

Get This & Last Year’s Report(s): March 2016* & May/June 2017 ASTRs Options:

Normally priced at $2,397.00 Web Special $1,997.00 for the:

March 2016* & May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTRs OR

March 2016* & May/June 2017 Home Use MEE&S ASTRs

Normally priced at $3,697.00 Web Special $2,997.00 for the:

Bundle pricing for all 4 Reports – March 2016* & May/June 2017 of both MEE&S & Home Use MEE&S ASTRs

* = MAR ‘16 ASTRs issued as of MAR ‘16 with no updates for these ridiculously low rates.

If you need help with IEC 60601-1 please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants and considered the ‘IEC 60601 Guy’ by many of his clients and associates.

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.

Eisner 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:

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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.