Eisner Safety Consultants: Qmed Qualified Supplier
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Standards Reconnaissance Subscription Service Coming Soon

Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for […]

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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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Can an OSHA NRTL Certify to ANSI/AAMI ES60601-1:2005/(R)2012 with Amendments Yet?

This article discusses OSHA’s release of ANSI/AAMI ES60601-1:2005/(R)2012 + Amendments & timing of @ least 1 NRTL’s authorization to use it. On 27 March 2014 OSHA announced thru a Federal Register Final Notice that they are incorporating new test standards into the list of ‘Appropriate NRTL* Program Test Standards’.  With this announcement they have officially […]

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IEC 60601 Medical Electrical Equipment Classifications: FAQ’s

IEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog.  Why do I need to classify my product for IEC 60601-1, 3rd ed.? – The standard says you have to classify“…ME EQUIPMENT, or parts thereof, including applied parts…” as noted in sub-clause 6.1 of IEC 60601-1, 3rd ed or 3rd ed. with Amendment 1 […]