Sign-up to our Newsletter

Loading...Loading...


Eisner Safety Consultants: Qmed Qualified Supplier
Print This Post Print This Post

Wearables the rage but are they medical devices?

Guidance documents to help you determine if your Wearable device is a medical device that needs FDA approval or not for US submissions. Wearables may be the rage but what does your company need to do for an FDA medical device submission in the US (or do you even need one from the FDA?) with [...]

Print This Post Print This Post

OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards

OSHA adding AAMI ES 60601-1 to the ‘List of Appropriate’ NRTL Program Test Standards is discussed in this blog. BIG News!!!  News, I have been waiting for many years now is that OSHA, finally, under it’s NRTL (Nationally Recognized Test Lab) program will be adding the US National version of the IEC 60601-1:05 + A1:12 [...]

Print This Post Print This Post

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 [...]

Print This Post Print This Post

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 [...]

Print This Post Print This Post

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 [...]