From MedicalDeviceSummit on Nov 10, 2011 – ‘The new iPad app CardioTeach has been touted as industry’s first at helping doctors communicate heart disease and treatment options to patients.’ There is a video demonstration of the CardioTeach™ iPad app Apple
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”.
DRAFT results implementation of 3Ed (EN60601 series) for CE marking
This article is an update to the June 24, 2011 article “EU EN IEC 60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity” On October 1, 2011 the DRAFT “FAQ related to Implementation of EN
EU REACH Rprt DCG’s Achievements, Lessons Learned & Recommendations
On 20 September 2011 a Report was issued from the Directors’ Contact Group between Commission, ECHA & Industry Associations on Meeting the 1st REACH Registration Deadline. The first deadline period was from FEB 2011 to MAR 2011. The Notes and
RoHS Recast Implications to EU Med & IVD Devices
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU. You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF. With the exception of