Join us at the 2013 RAPS Regulatory Convergence Conference (Boston) in the Medical Device Track on IEC 60601-1 Third edition: Managing Human Factors and Usability Risks. Your experts that will help you through these issues are Leo Eisner of Eisner
Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance
Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to
Impact of the Draft report on the EU MDD proposed regulations
This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com) If you are reading this post my guess
MEDDEV 2.12-1 Guidelines on Medical Devices Vigilance System Updated to Rev 8
This blog post is thx to our associate Christine Ruther and a special thx goes out to Helene Spencer. MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013. The revised guidance is applicable as of July
Med Electronic Dvc Soln’s Trade Pub’ed Article by Leo Eisner on FDA Home Use Draft Guidance Doc
The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012. The article that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled FDA Issues Draft