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  • RSG Medical Engineering LLC

    • Engineering
    156 East Bare Hill Road
    Harvard, MA 01451
    (978) 618-1994
    • About

      Medical device systems engineering services - expertise in origination of design inputs, requirements, architecture, risk management and safety/regulatory strategy for medical devices, including patient-applied transducers/sensors. Product development experience includes regulatory compliance necessary to gain FDA clearance and CE Marking, including orienting device design to meet IEC 60601-1:2005 + A1:2012 and EN ISO 14971:2012 constraints.

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