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Free Webinar – What You Need to Know About Medical Electrical Standards Updates

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 “What You Need to Know About Medical Electrical Equipment Standards Updates (& How They Affect Your Regulatory Strategy)” December 19, 2016 1PM ET/10AM PT.  Sign-up now for the limited live seating of the free webinar.

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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.

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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.

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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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510k Submission Workshop in Amsterdam Oct 11 – 12 ’17

Medicine doctor hand working with modern computer interface

October 11-12, 2017 there is a two-day, Medical Device Academy Amsterdam 510k workshop for medical devices at the Doubletree by Hilton Amsterdam Centraal Station. Medical Device Academy is hosting this event.

The Amsterdam 510k Workshop begins at 9am, and registration begins at 8am. A networking lunch is included in the City Cafe. Attendees receive a physical copy of the presentation slide deck, a hardcopy of the book “How to Prepare Your 510k in 100 Days,” and a flash drive with a complete set of 510k document templates. More important than what you receive, is what you will learn.

Register for Amsterdam 510k workshop on October 11-12, 2017

Amsterdam 510k Workshop 2017 – Wednesday, October 11 and Thursday, October 12.

Price: $995.00 
Select Pay button on Medical Device Academy 510(k) Workshop web page to purchase

Medical Device Academy can also invoice you for the Amsterdam 510k workshop if you prefer or provide a receipt invoice for tax purposes. Just send an email to: rob at 13485cert dot com.

You can ONLY get the 510(k) book by attending Medical Device Academy’s Amsterdam 510k workshop or by purchasing the on-line 510k course.

Where is the Amsterdam 510k workshop located?Exterior 300x200 Amsterdam 510k Workshop on October 11 12, 2017 ($995)

DoubleTree by Hilton Amsterdam Centraal Station

Oosterdoksstraat 4, Amsterdam, 1011 DKNetherlands

Call for Directions & Reservations: +31-20-5300800

Go to Medical Device Academy 510(k) workshop web page in order to get reduced hotel rates when you register – Starting at 224

Sponsors for Amsterdam 510k Workshop

Medical Device Academy is a consulting firm that helps medical device companies with regulatory submissions, establishing new quality systems, internal/supplier auditing and training.

FDA eCopy is a service provided to device manufacturers and other regulatory consultants to help prepare, review, edit, print and ship FDA eCopy submisisons. We routinely prepare, review, edit, print and ship 510(k) submissions and pre-subs to the FDA with overnight FedEx shipping.

Factory-CRO is a global clinical research organization (CRO) that specializes in medical device and IVD clinical studies. The company manages clinical studies in Europe for CE marking and in the USA for FDA submissions. For more information, please download the company information sheet.

Matrix Requirements Medical is a web-based software database for documenting your device requirements to meet the global regulatory requirements for design controls and risk management. The founders of the company are experienced device developers with medical device software development experience–including IEC 62304. The company is located in Brussels, Belgium. However, their clients are global and they have numerous testimonials on their website from satisfied customers. They also have a product demonstration to show you how the database makes documenting design controls and your risk management file easier.

What you will learn in the Amsterdam 510k workshop

Rather than spend a little time on every aspect of a 510k submission, instead I will be focusing on the most important parts of a 510k submission with stories, examples and exercises. Our speakers will cover:

  • How to select a predicate device – presented by Rob Packard
  • How to write the indications for use (Section 4) – presented by Rob Packard
  • How to create a testing plan – presented by Mary Vater
  • How to manage your 510k project – presented by Mary Vater
  • Biocompatibility (Section 15) – presented by Thor Rollins
  • Software Validation (Section 16) – presented by Wolfgang Huber
  • Electrical Safety & EMC Testing (Section 17) – presented by Leo Eisner
  • Human Factors Testing (Sections 13 & 18) – presented by Adam Shames
  • Clinical Study Testing (Section 20) – presented by Niels van Tienen

Niels van Tienen recorded a free webinar on the topic of clinical studies on Wednesday, August 9th.

Mary Vater recorded a free webinar on the topic of implementing risk management and design controls as part of your 510(k) project on Wednesday, August 16th.

Leo Eisner is presented a free webinar providing a status update on IEC 60601 Standards for Medical Electrical Equipment on August 23rd, 2017.

Rob Packard is presenting a free webinar on how to create an FDA eCopy on August 30th, 2017.

Adam Shames is presenting a free webinar on Human Factors Testing on September 6th, 2017.

Wolfgang Huber is presenting a free webinar on Traceability Matrices for Software Validation on September 13th, 2017 @ 10:00am EDT.

Thor Rollins was not available to provide a free webinar prior to the Amsterdam 510k Workshop, but Nelson Labs has two on-demand webinars by Thor Rollins available on their website. Thor will also be attending MedTech Irelandthe week before the Amsterdam 510k Workshop.

We will be collecting specific questions from registrants in advance to ensure that we include the areas that are most important to you. We have content from 24 webinars, covering each section of a 510k submission, and templates for each document. Therefore, we can review any section of a 510k in detail.

Click on the button below to download an information brochure.

click here button 1487274 960 720 150x150 Amsterdam 510k Workshop on October 11 12, 2017 ($995)

Speaker biographies for the Amsterdam 510k workshop

Pix Rob Packard zoom 150x150 Amsterdam 510k Workshop on October 11 12, 2017 ($995)

Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+LinkedIn or Twitter.

Cropped Pix of Niels van Tienen 150x150 Amsterdam 510k Workshop on October 11 12, 2017 ($995)

Niels is Director of Education and Training for Factory-CRO in the Netherlands. Factory-CRO’s clinical team organizes and supervises clinical investigations in Europe and the US, including a variety of medical writing activities for medical devices companies. Factory-CRO provides regulatory, clinical trial and clinical evaluation services. Niels is responsible for managing clinical study projects for medical device and IVD clients, and he has a Health Science Masters Degree from Maastricht University. He will be a guest speaker at the Amsterdam workshop sharing his Clinical Study Testing (Section 20) expertise. Niels also presented a free webinar on Medical Device Clinical Study Requirements on August 9, 2017.

Niels Van Tienen MSc – Director, Education and Training

Phone: +31 30 229 2727 (x171) | Cell: +31 6 52357492| Email: n.vantienen at factory-cro dot com

Prof. Bronkhorstlaan 10 Bld. 54 | 3723 MB Bilthoven | The Netherlands

35ebc9d Amsterdam 510k Workshop on October 11 12, 2017 ($995)Leo is the Principal Consultant of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering, an expert in product safety for medical electrical devices (IEC 60601 series of standards), has been heavily involved in standards development focused on the IEC 60601 series of standards including working on IEC 60601-1, 3rd ed. + Amendment 2 (due out late 2019), has worked for several Notified Bodies as an auditor & technical reviewer, and is an expert in CE marking for the medical device directive.  He has over 30 years experience in product safety, and he routinely speaks all over the world as an international expert on the topic of electrical safety and IEC 60601-1. During the Workshop Leo will be discussing Electrical Safety & EMC Testing (Section 17).

Leonard (Leo) Eisner – Principal Consultant of Eisner Safety Consultants

Phone: +1 503 244 6151 Cell: +1 503 709 8328 Email: leo at eisnersafety dot com

3331 SW Seymour Street Portland OR, 97239

Mary Vater Amsterdam 510k Workshop on October 11 12, 2017 ($995)Mary is a biomedical engineer and consultant with Medical Device Academy. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices and standalone software. She also has experience with CE Marking and Canadian Licensing application. She served both as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas.  As a guest speaker, Mary is going to explain how design controls and risk management should be integrated with the process of your 510k preparation.

 

Mary Vater – Consultant for Medical Device Academy

Email: mary at fdaecopy dot com

adam headshot 240x300 150x150 Amsterdam 510k Workshop on October 11 12, 2017 ($995)Adam is a human factors expert. He has an M.B.A. in International Business from the Fox School of Business and Management at Temple University and a B.S. in Human Factors Engineering and Psychology (double major). From Tufts University. He has over a decade of extensive research experience, and has conducted hundreds of usability studies with thousands of participants around the world. He has also been the principal investigator on numerous successful IRB reviewed studies. As a guest speaker, Adam will be explaining how to design and conduct human factors studies for your 510k submission.

Adam Shames – Founder & CEO of Core human Factors, Inc.

France Office: 10 rue du Colisée 75008 PARIS

Phone: +33 (0)1 56 88 49 17

Email: shames at corehf dot com

Head Shot from LinkedIn for Wolfgang Huber 150x150 Amsterdam 510k Workshop on October 11 12, 2017 ($995)Wolfgang Huber is Co-Founder of Matrix Requirement Medical. He is a software engineer that will be speaking on IEC 62304 and the requirements for software documentation in a 510k submission. His company developed a web-based application to help medical devices organize documentation (requirements, specifications, use cases, tests, risk analysis) for their Design History File (DHF). The software eliminates the need to exchange word documents, maintains version control and automatically creates a traceability matrix. The company website includes testimonials for customers that use the software for creating their 510k submission documents.

Wolfgang Huber – Co-Founder of Matrix Requirement Medical

Email: wolfgang at matrixreq dot com

Thor Rollins Cropped Amsterdam 510k Workshop on October 11 12, 2017 ($995)Thor Rollins is Director of Toxicology and Extractables and Leachables (E&L) Consulting at Nelson Laboratories, LLC in Salt Lake City, Utah. He is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs external seminars, webinars and tradeshows. He presented on biocompatibility at the Northern Cali Biomed ASQ group meeting in 2010 and 2012 as well as published articles on biocompatibility topics.

He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.

Thor Rollins – Director, of Toxicology and Extractables and Leachables (E&L) Consulting Nelson Labs

Phone: +1.801.290.7832

Email: trollins at nelsonlabs dot com

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EU MDR & IVDR Have Been Published in OJEU 5 May 2017

European Union


Update of May 5 2017 Addition of the Published Documents

“EU MDR & IVDR were  Published in OJEU TODAY Friday May 5, 2017″

Stop the Presses and add these earth shattering Regulations to your reading list for the next week or two:

Bassil Akra of TÜV SÜD some of the costs of this transition in his post on LinkedIn. It ain’t going to be cheap!

Back to our regularly scheduled post:

This Friday 5 May 2017 should be marked in your calendar or journal as a momentous date when the EU Official Journal will publish the Medical Device and In-Vitro Diagnostic Regulations and the transition periods for both start (3 years for the MDR & 5 years for the IVDR)!!  This is the start of a turning point for many medical device and IVD manufacturers as the clock starts ticking away til the end of the transition periods of these new Regulations.  If you haven’t started your transition planning strategies for your products & product families the pressure should be mounting quickly as there is so much to deal with for this transition time. Check out these resources for learning more about the MDR & IVDR. See below for some more details about the challenges you need to consider and START PLANNING for NOW (don’t wait)!

There is no grandfathering once the transition period ends for the applicable Regulation.  So, in 3 years and a day or so if you don’t meet the MDR or 5 years & a day or so if you don’t meet the IVDR you won’t be able to CE Mark your device and sell or distribute your medical or IVD device in the EU (& hopefully the UK which is in the middle of Brexit implications as UK will not be part of the EU by end of transition period).

We have talked about some of the challenges in the implementation of the MDR but here are more details to consider for your strategic planning:

  • New definitions to deal with including nanomaterial, Unique Device Identifier, interoperability, economic operator, among other new & modified definitions.
  • Person Responsible for Regulatory Compliance: Identify personnel that is  responsible for regulatory compliance with the Regulation and have a minimum work experience in the applicable device field and a minimum of academic qualifications.
  • Enormous Single EU Database (not ready yet): Impacts all Economic Operators (which includes manufacturers) – Will register all devices, manufacturers, Economic Operators, CE Certificates, new clinical investigations, & incident reporting.  Will manage all Unique Device Identifications and Single Registration Numbers (SRN).
  • Regulations are much more explicit now for the Quality Management System (QMS) & Risk Management System (RMS) requirements.  Beyond just what is in EN 13485 (ISO 1385:2016) & EN 14971
  • Economic Operators (new to MDR): Impacts the activities of EU Representatives, Importers, Distributors & Manufacturers – Different Responsibilities depending on type of Economic Operators.
  • Traceability of Devices Between Economic Operators: Between all Economic Operators (wow that in itself can be huge!) and all the way down to the healthcare institutions & in some cases down to the patients devices used on.
  • Annex I now called Safety & Performance Requirements (not Essential Requirements): Much more prescriptive, addition of UDI & SRN to labelling requirements, all manufacturers will need to update all their Annex I checklists, new Clinical Evaluation & Clinical Performance Evaluations requirements
  • Clinical Data: Much more prescriptive especially for higher risk class devices (class III & implantable devices) – Clinical Investigations needed in many cases now & restrictions of the type of clinical data allowed for class III devices (much more restrictive using equivalency data), post market clinical follow-up requirements for high risk class devices (i.e. annual summary reports for Class III & implantable devices).
  • Notified Bodies: Much more prescriptive in competency requirements, conflict of interest, designation process, etc.  The end result is fewer Notified Bodies & Notified Bodies with narrower scopes after the designation process.  Also, with the nexus of  the EU regulations, Canada’s MDSAP requirements, and medical device manufacturers transitioning to ISO 13485:2016 the Notified Bodies resources are being strained which means less resources available to the medical device manufacturers. The limited resources means it may be a challenge to complete these processes without hitting the edge or past the transition period so start now or you may not be able to keep all your CE medical devices on the EU market in about 3 years from now when the clock runs out.

If you need help with your EU MDR or IVDR transition planning 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.

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IEC 60601-1, 3rd ed. + A2 Anticipated ’19 – Annual Standards Trends Reports Web Special

Updated April 30 to extend Web Special til end of May ’17

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.

 

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EU MDR & IVDR – Final Versions – Are You Ready (Updated 7, 12, & 17 March ’17)

European Union and Europe countries including France Germany Italy and England surrounded by blue ocean with three dimensional yellow flag stars on a blue grunge background.

Since our original post (below) we have made 3 additional updates to provide you with a lot more info and resources.  Check out our updates in this LinkedIn Article.

Updates are all underlined:

Mar 7, ’17 updates:

* addition of the EU Council vote & date of release of final text

* an important change that manufacturers will need to deal with, and

* addition of 4 resources to list of helpful resources

Mar 12, ’17 update: add in Table of Contents LinkedIn Article

Mar 17, ’17 update: RAPS Article by Rod Ruston

Our original post was on March 1, 2017 is titled EU MDR & IVDR – Final Versions – Are You Ready, Transition Period Starts Soon.

If you need help with your EU MDR or IVDR transition planning 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.