Eisner Safety Consultants: Qmed Qualified Supplier

Where is EU headed with Proposed Medical Device Regulations by ENVI?

The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of devices.  Note, this issue is not set in stone and you should read some of the […]

MD&DI Articles on Home Use FDA Draft Guidance & Be Aware

This post deals with the FDA’s Draft Guidance on Home Use Devices.  But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for 1 deal).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 […]

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

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

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? MD&DI

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