MedTech Dive November 13, 2023
The US Food and Drug Administration (FDA) recently announced its support of the Case for Quality Voluntary Improvement Program (VIP) through a final Guidance published in September. VIP delivers improved organizational performance and product quality, with the ultimate goal of providing reliable and safe treatments to patients faster.
The Voluntary Improvement Program was developed in collaboration with the medical device industry, FDA, the Medical Device Innovation Consortium (MDIC) and ISACA.
Enterprise-wide Continuous Improvement: A Case Study
The Voluntary Improvement Program leverages a tailored version of ISACA’s Capability Maturity Model Integration (CMMI) framework and appraisal methodology, to help medical device manufacturers better understand, measure and improve their capabilities to deliver high-quality products. By using the CMMI framework, organizations are able to...
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