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, Title 21, part 860 (21 CFR 860). Therefore we comply with FDA Good Manufacturing Practices (GMP)/Quality System (QS) Regulations requirements per Title 21, part 820 (21 CFR 820).
Michigan Instruments has also implemented and maintains a Quality Management System (QMS) which conforms to ISO 13485:2003 + AC:2009 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.