Standards/Regulations Update Srvc – Eisner Safety Consultants

Leo Eisner Presenting at RAPS/ASQ on IEC60601-1 3rd ed.

leoeisner — Fri, 28 Jan 2011 12:00:50 +0000

Biomedical Division Northern California Discussion Group andSan Francisco Bay Area Chapter

Topic: “Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas:

IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry
Usability and Human Factors verification, validation, and regulatory requirements
Clinical evaluation and investigation regulatory requirements

Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Geetha Rao, PhD, VP, risk management and strategy, Triple Ring Technologies, Inc; Ibim Tariah, technical director, BSI Healthcare; Craig J. Coombs, RAC, president, Coombs Medical Device Consulting, Inc.; and Juergen Stetin, president and CEO, PROSYSTEM AG

When: March 4, 2011 (Friday), presentations start right at 8:30AM check-in 7:45AM with Continental Breakfast

Registration Contact: Wesley Carr or call +1 301-770-2920 ext. 231 Registration form for event, must register by Feb 25, 2011, space is limited

Where: Crown Plaza Mid-Penisula, 1221 Chess Drive Foster City, CA 94404

ESC @ 74th IEC Gen. Mtg til Oct 16 ’10 – Med Elec Equip Comm’s TC62, SC 62A & 62D

leoeisner — Mon, 11 Oct 2010 00:01:05 +0000

Eisner Safety Consultants is attending the 74th Annual IEC General Meeting in Seattle Washington thru Oct 16, 2010. As a US National Committee member of Technical Committee (TC) 62, Subcommittees (SC) 62A & 62D we are attending the committee meetings that will help medical device manufacturer’s better understand the coming & current standards requirements. We are here so we can help our clients. So, please contact us to help your company through IEC 60601-1, 3rd ed. Gap Analysis and to help your company to stay on top of the ever changing & evolving IEC 60601 series of standards. Go to www.EisnerSafety.com/contact_eisner_safety/ to contact us.

AAMI News: Online Med Dvc Stan…

eisnersafety — Tue, 16 Mar 2010 19:49:44 +0000

AAMI News: Online Med Dvc Standards Portal Access to Over 2,000 Std’s & Reg’s (AAMI, ANSI, ASTM, DIN, IEC/ISO, FDA) http://ow.ly/1n2Jg

Eisner Safety Consultants Newsletter #1 Available

leoeisner — Sun, 20 Sep 2009 00:00:51 +0000

ESC Newsletter #1 – Just Released

This newsletter contains articles on IEC 60601-1, 3rd ed (published in MD&DI – Sept ’09), The Amendment to the Medical Device Directive, Pre-Announcement of our Gap Analysis & Update Package for the MDD Amendment 2007/47/EC, our Standards & Regulations Update Service, announcement of the Medical Device Track at the Oct ’09 IEEE Product Safety Engineering Society, and on the launch of Eisner Safety Consultants New Website.

Subscribe to the newsletter to get future newsletters. Go to any page on the website www.EisnerSafety.com and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.