US – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Thu, 18 Oct 2012 21:55:43 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png US – Eisner Safety Consultants https://eisnersafety.com 32 32 L. Eisner Talk 13 Dec on IEC 60601-1, 3rd ed. – US, EU, Japan, Brazil, & Canada National Implementation https://eisnersafety.com/2012/10/18/l-eisner-talk-13-dec-on-iec-60601-1-3rd-ed-us-eu-japan-brazil-canada-national-implementation/?utm_source=rss&utm_medium=rss&utm_campaign=l-eisner-talk-13-dec-on-iec-60601-1-3rd-ed-us-eu-japan-brazil-canada-national-implementation Thu, 18 Oct 2012 21:55:43 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2785 Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition – Where Do We Stand on National Implementation?” via FX Conferences on Dec 13, 2012 at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  He will be discussing the National Implementation for the US, EU, Japan, Brazil, & Canada.

You don’t have to leave your office to join in on the presentation and as a special thank you for visiting us at Eisner Safety Consultants you can get a 20% discount.  To find out more about the presentation & discount just click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

]]> Eisner Safety Consultants to Restart Monthly Newsletter Service https://eisnersafety.com/2012/07/31/eisner-safety-consultants-to-restart-monthly-newsletter-service/?utm_source=rss&utm_medium=rss&utm_campaign=eisner-safety-consultants-to-restart-monthly-newsletter-service Tue, 31 Jul 2012 22:40:39 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2620 It has been over 2 years since we sent out our last newsletter.  Our apologies.

We have decided to send out a monthly update of our blog posts for each month which are all located at www.EisnerSafety.com/Industry_News/.  We have been working out the bugs for the last few weeks and we are ready to go live as of today, 31 July 2012 evening (Some may receive your copy on 1 August).  If you haven’t viewed our blog posts in the last several months there have been some significant posts covering a lot of issues around national implementation of IEC 60601-1, 3rd edition (Japan, article on US, Canada, EU & Brazil) and Amendment 1 (just released); EU Competent Authorities formed Central Management Committee (CMC) for medical device sector & Issued Four Decisions; and much more.  You can also view our posts on Twitter at our Twitter feed at http://Twitter,com/EisnerSafety/.

If you would like to sign up for our newsletter please go to any of our webpages and enter the info in the upper left hand corner where it says “Sign-up to our newsletter”.

Do you have any feedback on the new monthly newsletters please feel free to let us know your thoughts on topics you would like to see in future posts or other suggestions are gladly welcome.  Send e-mail to info@EisnerSafety.com.

]]> Update on National Implementations of IEC 60601-1:2005 https://eisnersafety.com/2012/04/29/update-on-national-implementations-of-iec-60601-12005/?utm_source=rss&utm_medium=rss&utm_campaign=update-on-national-implementations-of-iec-60601-12005 Sun, 29 Apr 2012 06:00:47 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2512 This article was written by Leo Eisner and is featured in the Journal for Medical Device Regulations in their May 2012 edition.  It is the top article on our Featured Articles WebPage.  This article is on the National Implementations of IEC 60601-1:2005 for the EU under the MDD & AIMDD, Canada under the purview of Health Canada via the Canadian Medical Device Regulations (CMDR), United States of America under the purview of the Food & Drug Administration (FDA), and Brazil under the purview of the National Health Surveillance Agency (ANVISA).  

Enjoy the article!

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