InCompliance Magazine – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Sun, 12 Jun 2022 18:15:36 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png InCompliance Magazine – Eisner Safety Consultants https://eisnersafety.com 32 32 IEC Article on IEC 60601 Series Amendments Project https://eisnersafety.com/2021/04/11/iec-article-on-iec-60601-series-amendments-project/?utm_source=rss&utm_medium=rss&utm_campaign=iec-article-on-iec-60601-series-amendments-project Sun, 11 Apr 2021 23:15:59 +0000 https://eisnersafety.com/?p=6885

A good summary article on IEC e-Tech News about the IEC 60601 Series Amendments project that published last summer (2020) the General 60601-1, and Collateral standards (60601-1-XX). Please note that you need to read further comments in some of my articles about IEC 60601-1 for IEC 62368-1 and IEC 60601-1-2 for some additional details. One blog post is an article from InCompliance

]]> IEC 60601 Amendments Updates Have Published: Changes and Impacts https://eisnersafety.com/2020/11/16/iec-60601-amendments-updates-have-published-changes-and-impacts/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-amendments-updates-have-published-changes-and-impacts Mon, 16 Nov 2020 22:56:31 +0000 https://eisnersafety.com/?p=6824 In the November issue of InCompliance Magazine I discuss the IEC 60601 Amendments Project, which includes the IEC 60601-1 General standard and the Collateral standards (IEC 60601-1-XX standards but for IEC 60601-1-3), and some of the changes to the General and Collateral Standards of the Project, and their impact on manufacturers. The future of the IEC 60601 series of standards is also covered.

I identify which of these standards have major changes when they were published, and discuss some of the changes.

View all the articles I have written for InCompliance Magazine.

I hope you enjoy this article and if you have any questions please feel free to schedule a call with me.

]]> InCompliance Annual Guide Articles https://eisnersafety.com/2020/03/01/incompliance-annual-guide-articles/?utm_source=rss&utm_medium=rss&utm_campaign=incompliance-annual-guide-articles Sun, 01 Mar 2020 09:23:55 +0000 https://eisnersafety.com/?p=6686

As a Senior Contributor to InCompliance, many years I am asked to update my articles to be placed in the Annual Guide but rarely do 2 of my articles show up in the Guide in a year. This year 2 of my popular articles have worked there way into the annual guide.

THE EU’S MEDICAL DEVICE REGULATION (EU) 2017/745 – ARE YOU READY FOR HUGE SWEEPING CHANGES?

The article now starts off with “Less than 3 Months Left to Implement the EU MDR“. The article was originally written on June 28, 2019, and updated on February 1, 2020.

THE FUTURE OF THE IEC 60601 SERIES: AN UPDATE

“I have been writing and talking about the IEC 60601 series of standards for a very long time, but I have presented on this subject more often in the last couple of years since there is so much changing on a regular basis.” The article was originally written on October 31, 2019, and updated on February 1, 2020.

]]> Faces in Compliance https://eisnersafety.com/2020/02/26/faces-in-compliance/?utm_source=rss&utm_medium=rss&utm_campaign=faces-in-compliance Wed, 26 Feb 2020 05:01:17 +0000 https://eisnersafety.com/?p=6674

As a Senior Contributor to InCompliance Magazine, I have been fortunate to been asked to be part of this special supplement where InCompliance Magazine is featuring people that have been involved in Medical Device Compliance and Standards Development for a long time, like me, Leo Eisner. The Faces in Compliance is a short snapshot of my story. If you want to hear more about my story please feel to contact me at Leo@EisnerSafety.com.

Need help with compliance support with IEC 60601 series of standards or regulatory support please schedule a call.

]]> The Future of the IEC 60601 Series: An Update https://eisnersafety.com/2019/12/07/the-future-of-the-iec-60601-series-an-update/?utm_source=rss&utm_medium=rss&utm_campaign=the-future-of-the-iec-60601-series-an-update Sat, 07 Dec 2019 06:15:26 +0000 https://www.eisnersafety.com/eisnersafetycom/?p=6268

Read the article I wrote for InCompliance Magazine recently. I just got back from China at the end of Oct 2019 where I was at IEC meetings for 2 weeks working on IEC 60601-1, edition 3.2 and it’s collaterals and discussing the 4th edition architecture, as well. This article discusses all of this and where things are headed. Hold on as things are continuing to change.

I hope you enjoy this article and if you have any questions please feel free to contact me at Leo at EisnerSafety dot com or schedule a call with me www.EisnerSafety.com/Schedule-Call/.

]]> Standards & Regulatory Update – Medical Electrical Devices – Article https://eisnersafety.com/2018/06/15/standards-regulatory-update-medical-electrical-devices-article/?utm_source=rss&utm_medium=rss&utm_campaign=standards-regulatory-update-medical-electrical-devices-article Fri, 15 Jun 2018 00:09:57 +0000 https://www.eisnersafety.com/eisnersafetycom/?p=6112 In the June issue of InCompliance Magazine I provide advice in an article on how to remain current on medical electrical device standards (including those in development) and regulatory guidance documents.  I start up at the International level (IEC & ISO) and then also discuss the US (FDA), Canada (Health Canada) and the EU (Notified Bodies under the MDD currently and in process of transitioning to the MDR).  I discuss the structure of the IEC 60601 standards series, what Technical and Sub Committees under IEC and ISO these standards are under and also discuss some of the related standards such as IEC 62304 (Software Lifecycle Processes), IEC 62366 (Usability), etc.  Part of what makes things hard for medical device manufacturers on top of all the changes to standards is there is a lot of change going on in the regulatory and quality system space as I discuss some of the challenges medical device manufacturers are currently facing over the next couple years.

View all the articles I have written for InCompliance Magazine.

I hope you enjoy this article and if you have any questions please feel free to contact me at Leo at EisnerSafety dot com or schedule a call with me.

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