Risk Management Standard – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Fri, 31 Jan 2014 21:29:34 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Risk Management Standard – Eisner Safety Consultants https://eisnersafety.com 32 32 Leo Eisner Track Chair at MD&M West Conf 11-Feb Discuss EN ISO 14971:2012 https://eisnersafety.com/2014/01/31/leo-eisner-track-chair-at-mdm-west-conf-11-feb-discuss-en-iso-149712012/?utm_source=rss&utm_medium=rss&utm_campaign=leo-eisner-track-chair-at-mdm-west-conf-11-feb-discuss-en-iso-149712012 Fri, 31 Jan 2014 21:29:34 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=3611 UBM Canon Communications has graciously asked me to join this year’s MD&M West Conference with the honor of being the track chair for the Risk, Quality & Validation track on Tues 11 Feb 2014.  We have a great line up that day so please come join us.  

To kick-off the morning for our track I will be talking briefly on a draft document that NB-MED & COCIR & some other organizations are working on to help clarify what is expected of medical device manufacturers when relying on EN ISO 14971:2012 which is a document that has totally muddied the waters.

I am in direct contact with the authors of this consensus based document and we are working on finalizing what I will be presenting to you at the conference. So, expect some up to the date information about this document and we may be asking for feedback from industry too.  Stay tuned for any updates to this post too.  I look forward to presenting this material to the conference participants.

If you need help with the Risk Management File concepts within the IEC 60601 series of Standards, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

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