Founded in 2000 by clinical laboratory scientists Joan Gordon and Clark Rundell, Maine Molecular Quality Controls designs and manufactures molecular quality controls for inherited-disease and infectious-disease testing. Based in Saco, the company grew from Rundell’s patented method for stabilizing DNA constructs and Gordon’s manufacturing protocols, and it continues developing controls for emerging nucleic-acid technologies and custom in vitro diagnostic applications. Its quality system is certified to ISO 13485:2016 and supported by MDSAP accreditation.
ISO 13485:2016
Medical Device Single Audit Program (MDSAP)
Compliance program
cGMP manufacturing facility
Compliance program