Eisner Safety Consultants» MD&DI

MD&DI Interview Leo Eisner re:NB-MED Draft Doc EN60601 Implementation for EU

leoeisner — Tue, 11 Oct 2011 19:15:04 +0000

On Oct 6, 2011 MD&DI (Heather Thompson) interviewed Leo Eisner of Eisner Safety Consultants in regard to his blog posting on the NB-MED draft document “FAQ related to implementation of EN 60601-1:2006 Clarification of open issues”.

Stricter 510(k) Process Offers Challenges, Promises

leoeisner — Wed, 20 Oct 2010 17:36:24 +0000

From MDDI Magazine – Sept 2010 – “FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices are appropriate for the approval pathway and when those applications would require additional evidence of both safety and efficacy. These recommendations will be open for public comment.” To read the whole story click here.

Later in the article there are Highlights of Proposed Changes to 510(k)

Just Say No to FDA’s Idea of Transparency? MD&DI

eisnersafety — Fri, 20 Aug 2010 00:09:36 +0000

Just Say No to FDA’s Idea of Transparency from MD&DI Magazine Aug-10 http://ht.ly/2sa6c See our post FDA Issue Assessment of 510(k) for the FDA assessment report on the 510(k) process

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”.

MD&DI Sept ’09 Article on IEC 60601-1, 3rd edition

leoeisner — Tue, 01 Sep 2009 00:00:04 +0000

Regulatory Strategies for the Third Edition of IEC 60601-1 — Published September 2009 in MD&DI

The article discusses when IEC 60601-1:2005 will be mandatory, including the US, EU, & Canadian National versions. There is a look at the development of the standard and why implementation has taken so long. As there can be conflicting requirements for the manufacturers the article discusses the steps to consider in developing a company strategy to transition from second to third edition for its product lines. This last item is a special segment in the web version only.

Reducing Risk without Wasting…

eisnersafety — Sat, 02 May 2009 04:32:34 +0000

Reducing Risk without Wasting Resources: Doing Risk Management Right

MD&DI May ’09 article on Risk Management by Mike Schmidt