Eisner Safety Consultants

Eisner Safety Consulting Newsletter Archive

Issue 6 – June 30, 2010

• IEC 60601-1, 3rd ed. Big News
  • FDA formally Recognizes AAMI ES 60601-1:2005, mandatory 7/1/2013
  • CENELEC posts updated EN60601 Series FAQ
  • UL white paper on IEC 60601-1, 3rd edition Regulatory Decisions
  • ANSI/AAMI/IEC TIR62354:2009 – testing procedures for Medical Electrical Equipment
• MDD Classification MedDev 2.4.1 updated to include 2007/47/EC amendment
• TÜV SÜD Information Bulletin on Updated Clinical Data Requirements
• Are you prepared when your Notified Body Requests Usability Analysis or Clinical Data?
• Does your medical device use Inductive Coupling to recharge batteries?

Issue 5 – March 17, 2010

• IEC 60601-1, 3rd ed. Audio Conf. $50 Off
• MDD Amendment Less than 1 week til Mandatory
• Important 60601-1 News
• 3 Ways How to get your ESC Regulatory & Compliance Updates

Issue 4 – January 21, 2010

• MDD Amendment 2007/47/EC Audio Conference
• MEDDEV Guidance Updates to Align with MDD Amendment 2007/47/EC
• Are You Prepared For The MDD Amendment Changes? Less Than 2 Months Left to Get Ready!
• Associate Profile of Alf Dolan

Issue 3 – November 3, 2009

• $50 off IEC 60601-1, 3rd Ed. Marking & Labeling Audio Conf.
• EN60601 Series in Relation to EU MDD & AIMDD
• Big Changes for EMC Standards IEC 60601-1-2, 4th Ed. & IEC 6XXXX, 1st Ed.
• Are You Prepared For The MDD Amendment Changes?

Issue 2 – October 5, 2009

• MDD Amendment Toolkit Now Available
• MDD Amendment Implementation Guide
• EU Vigilance Reporting
• Record Retention Times

Issue 1 – September 15, 2009

• New ESC Website
• MD&DI article on IEC 60601-1 3rd edition
• MDD Amendment
• MDD Gap Analysis & Update Package
• Standards & Regulations Update Service
• 2009 IEEE PSES Symposium – Medical Track