MindChild Medical, Inc. Announces ISO 13485 Approval

(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received ISO 13485:2003 certification for the design, development and manufacturing of its MERIDIAN family of non-invasive Fetal Monitors1,2,3,4 . ISO 13485:2003 certification precedes European pre-market submission of a Technical File submission5 , enabling European commercialization of the MERIDAN family of Fetal Monitors. MindChild previously announced 510(k) pre-market clearance of the MERIDIAN M100 Fetal Monitor. MindChild anticipates entering the US market with the MERIDIAN family of Fetal Monitor products following the FDA pre-market clearance of the current 510(k) notification. Additional pre-market regulatory filings are anticipated during 2016.