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Eisner Safety Consultants: Qmed Qualified Supplier
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Part 2 – Wearables the rage but are they medical devices?






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 that to determine if Wearables are medical devices you must a) review the definition of [...]

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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 [...]

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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.

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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 [...]

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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 [...]