Case for Quality Voluntary Improvement Program (CfQ VIP)
A program for medical device stakeholders to work together to enhance device quality and patient safety.
Program participants are eligible for regulatory modifications in the FDA’s pilot, which aims to elevate patient safety by leveraging CMMI as the framework by which medical device manufactures can measure their capability against best practices in a continuous improvement journey from compliance to quality.
Participation in the program requires a small investment of resources, both personnel and fees, however, there are several impressive benefits.
HTS CZ was able to analyze and quantify areas for improvement, and improving quality by 50%.
Cognizant improved their overall quality by decreasing delivered defects by 22%.
By customizing the estimating process, Unisys improved accuracy by 60%.
After just six months of CMMI deployment, Chemtech achieved a reduction in rework, saving almost $400,000.
G&P experienced striking results through the CMMI process improvement framework, with a 93% increase in the first quarter of 2016.
Reduces disruption and costs by $20K-$140K.
Increased innovation with more submissions, improved employee morale, faster time to market for device improvements, and re-deployment of FTE resources, saving $10k-$500k.
Easier and faster transfer of products for reduced distribution costs.
With a more streamlined submission process, products can reach market faster, to respond to patient needs.
Open conversations with the FDA help to improve working relationships.
ISACA surveyed early adopters of the Medical Device Discovery Appraisal Program to understand their experience.
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.
found no conflict with compliance to regulatory requirements.
Learn more about the Pilot Program’s results in this Case for Quality White Paper.
Understand how your organization compares against the overall medical device industry baseline.
Through a conversational-style approach, our experienced team of appraisers will measure your organization’s capability to deliver high-quality products.
The results are then summarized in a heatmap so that you can quickly identify areas of strength and gaps for improvement.
Discover how your organization compares against the rest of the medical device industry, and become part of a growing community that is learning from each other.
Still have questions about the appraisal? View our FAQs page for more details.
CeloNova’s investment in CMMI has enabled our start-up medical device company to deliver our cardiovascular innovations at or above the quality levels of larger, more established, medical device competitors. CMMI’s process challenges our Quality Management System assumptions while ensuring that we build an ‘end to end’ culture of quality throughout our organization.
Take a proactive approach to regulations and quality today! Submit this form to request a follow-up from an MDDAP representative to learn how to get started.
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View the program requirements, detailed information on the regulatory modifications, and available training.
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