FDA has announced “Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program” at https://www.federalregister.gov/documents/2017/12/28/2017-28044/fostering-medical-innovation-case-for-quality-voluntary-medical-device-manufacturing-and-product – contact us at Two Harbors for details.
“Through collaboration with the Medical Device Innovation Consortium (MDIC) over the last 2 years, a maturity model and appraisal system (i.e., Capability Maturity Model Integration (CMMI) system) that can be adapted for the medical device industry was selected for this CfQ Pilot Program. The CMMI system is a process level improvement, training, and appraisal program. The CMMI Institute administers this program whose stated goal is to help organizations discover the true value they can deliver by building capability in their people and processes. This model has been successfully used in various industries, including information technology, healthcare, automotive, defense, and aerospace to consistently deliver high quality products and reduce waste and defects. The CMMI Institute certifies and coordinates third party appraisers evaluating voluntary industry participants and any data necessary to demonstrate product performance. The appraiser would evaluate the firm’s quality system maturity and manufacturing processes, identify any gaps, and recognize when a participating firm performs above a compliance baseline. The CMMI maturity appraisal process is not intended to serve as an FDA inspection nor is it intended to be a new regulatory requirement. Conducting independent-assessments using a maturity model is intended to be a driver of continuous process and product improvement and add business value to voluntary participants in the CfQ Pilot Program.”
