Michigan Instruments product lines are certified and authorized
to be sold anywhere in the world. Our Resuscitation Technologies product
line is classified as a Class III Medical device by the Food and Drug
Administration.
Michigan Instruments has implemented and maintains a
Quality Management System which conforms to ISO 9001:2000 Quality
Management System Requirement and ISO 13485:2003 Medical Device Quality
Management Systems and fulfills the requirements of MDD 93/42 EEC, Annex
II.