Part 2 of series Posts – “General Wellness” & “Medical Device Accessories” FDA Guidances in regard to Wearables. Join us @ 10X conference & learn more From the previous “Wearables the rage but are they medical devices?” blog post I indicated
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
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
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
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