Eisner Safety Consultants: Qmed Qualified Supplier

Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ

EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.

What is the Scope of IEC 60601-1:2005 (3rd edition)?

This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product.  Definitions, third-party testing, etc. discussed. One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery operated […]

2013 RAPS Regulatory Conf. Presentation – IEC60601-1 3rd ed., Managing Human Factors & Usability Risks

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 Safety Consultants, and Mark Leimbeck and Michael Wicklund of UL LLC and will be presenting […]

FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032

The big news in the IEC 60601-1, 3rd ed. world today is the US National Standard that is in the FDA’s Recognized Consensus Standards Lists [Now is ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) – Recognition List #: 031, Recognition # 5-77] has had it’s transition date moved from June 30, 2013 to […]

South Korea MFDS Amends it’s Medical Devices Act & Will Require IEC 60601-1, 3rd ed + Amendments

There were three major changes to South Korea’s Medical Devices Act and the Enforcement of the Medical Devices Act as of 8 May 2013.