Eisner Safety Consultants

This post deals with the FDA’s Draft Guidance on Home Use Devices.  But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for 1 deal).  The MD&DI Editor-in-Chief, Heather Thompson, wrote two articles on the FDA Home Use Draft [...]

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”.

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 [...]

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

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 [...]