Set a New Pace for Medical Device Quality Improvement
The Medical Device Discovery Appraisal Program (MDDAP) helps medical device manufacturers better understand, measure, and improve their capabilities.
ISACA®, in collaboration with the FDA, Medical Device Industry Consortium (MDIC) and industry worked together to develop MDDAP to enhance device quality and patient safety.
The Case for Quality Voluntary Improvement Program (CfQ VIP), leverages MDDAP as the framework by which medical device companies can measure their capabilities against best practices.
The MDDAP framework is a tailored version of CMMI, specifically for medical device industry. The program enables medical device manufacturers to get appraised using the CMMI appraisal methodology to identify process improvement opportunities against a proven set of best practices to increase performance beyond compliance.
FDA grants program participants regulatory modifications, including streamlined submissions of PMA supplements and forgoing routine inspections, because of the manufactures increased transparency with FDA.
What Participants are Saying
reported the appraisal had provided overall value to the organization
believed the appraisal method provides a direct value to improving product quality
had a positive experience with the appraisal and 8% reported a neutral experience. No negative experiences were recorded