Eisner Safety Consultants: Qmed Qualified Supplier

NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

This post discusses NBRG’s call to participate in an Industry Survey on Industry’s Practice of Risk Management Process per EN ISO 14971:2012. On 7 February 2014 the Vice Chair of the Notified Body Recommendation Group, Michael Bothe, sent out a letter to industry to ask for their participation in a short survey (about 10 minutes long) […]

Leo Eisner Track Chair at MD&M West Conf 11-Feb Discuss EN ISO 14971:2012

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 […]

OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards

OSHA adding AAMI ES 60601-1 to the ‘List of Appropriate’ NRTL Program Test Standards is discussed in this blog. BIG News!!!  News, I have been waiting for many years now is that OSHA, finally, under it’s NRTL (Nationally Recognized Test Lab) program will be adding the US National version of the IEC 60601-1:05 + A1:12 […]

Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ

EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.

What is the Scope of IEC 60601-1:2005 (3rd edition)?

This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product.  Definitions, third-party testing, etc. discussed. One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery operated […]