MDIC contracted with Deloitte & Touche, LLC to conduct research concerning the use of maturity models in other industries. Although there are explicit regulations globally for medical devices and diagnostics, there is no recognized quality system maturity model. The objective of this research was to gain an understanding of various maturity models and how they have been implemented and leveraged within other industries. This information will be helpful to devise a plan for the potential development of a maturity model for use by both industry partners and regulators in the Medical Device industry.
Released June 2015