Assessing quality system maturity models that could help medical device companies drive quality beyond compliance
Posted by George Serafin, National Managing Director, Life Sciences & Healthcare on July 28, 2015.
Deloitte Advisory recently collaborated with the Medical Device Innovation Consortium (MDIC) to conduct research sponsored by the Food and Drug Administration (FDA) into quality system maturity models that other industries are using. MDIC is a public-private partnership collaborating on regulatory science to make patient access to new medical device technologies faster, safer, and more cost-efficient.
While there are already explicit regulations globally for medical devices and diagnostics, the industry does not yet have a widely recognized maturity model for quality management systems (QMS). The objective of this project was to recommend specific maturity model options that could be adopted by MDIC stakeholders, including medical device industry members and the FDA.1