Eisner Safety Consultants

Come join Eisner Safety Consultants at one or both conferences March 3 & 4th.  Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information [...]

  Biomedical Division Northern California Discussion Group  andSan Francisco Bay Area Chapter Topic: ”Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas: IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry Usability and Human Factors verification, validation, and regulatory [...]

Eisner Safety Consultants Newsletter #5 Now Online This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon.  Also, we would be remiss if we didn’t remind you that the MDD Amendment 2007/47/EC becomes mandatory this weekend [...]

The FDA is to Formally Recognize the Medical Electrical Safety Standard IEC 60601-1:2005, 3rd ed From AAMI March 12, 2010 press release The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.

3rd ed 60601-1 FX Conf on 3/25 “Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?” http://ow.ly/1j0o0