Michigan Instruments product lines are certified and authorized to be sold around the world. Offerings in our mechanical CPR product line are classified as “Class III” medical devices by the U.S. Food and Drug Administration (FDA) per the Code of Federal Regulations, (21 CFR 820). We comply with FDA Quality System Regulations (QSR) requirements (21 CFR 820).
Michigan Instruments has also implemented and maintains a Quality Management System (QMS) which conforms to ISO 13485:2003 and EN ISO 13485:2012 + AC:2012 Medical Device Quality Management Systems and fulfills the requirements of MDD 93/42 EEC, Annex II for all products. Offerings in our mechanical CPR product line are classified as “Class IIa” medical devices.
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For more information on the certifying authority, click here.