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Updated April 30 to extend Web Special til end of May ’17 (Note this service is not offered anymore please contact us with your questions.) Leo Eisner, the “IEC 60601 Guy” & Principal Consultant, of Eisner Safety Consultants attended several IEC
Do you want to ensure standards compliance to meet quality & regulatory requirements? Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed
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
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
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