What is the Voluntary Improvement Program?
The Case for Quality collaborative community Voluntary Improvement Program (VIP) was developed with FDA CDRH, MDIC, ISACA and the medical device industry. Participants can improve quality and patient outcomes with a combination of a globally accepted maturity model and FDA regulatory opportunities to accelerate device quality and manufacturing improvements.
The FDA Guidance “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program” details how the program rewards device makers’ commitment to continuous improvement by lessening regulatory burdens.
SEE IF YOUR ORGANIZATION QUALIFIESSee the improvement participants have reported
95%
REDUCTION IN COMPLAINTS PER MILLION
87%
REDUCTION IN TIME TO CREATE NCR AND CAPA REPORTS
65%
INCREASE IN DAILY PRODUCTION
32%
REDUCTION YEAR OVER YEAR IN COST OF POOR EXECUTION
As outlined by the FDA Final Guidance, participants may benefit from several opportunities to help accelerate improvements to device quality and manufacturing, including:
INSPECTIONS
A risk-based approach to FDA inspection planning and resource allocation for routine surveillance, pre-approval and post-market inspections.
30-Day Change Notices
Enables use of a modified submission format with reduced timeframes (resource permitting) for Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE).
SITE CHANGES
Enables use of a modified submission format with reduced timeframes (resource permitting) for PMA and HDE Manufacturing Site Change Supplements
MANUFACTURING MODELS
Program data enables use of a modified submission format for PMA or HDE Manufacturing Modules.
Participant reported benefits from the regulatory opportunities:
- Savings of 1000+ personnel hours and 90% of dedicated resources
- 75-90% faster review and approval of submissions
- Improved product quality, availability & cost
- Accelerated time to market
- Tens of thousands of dollars saved
Program participants reported:
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Case Study: How Innovize Was Able to Generate Higher Quality Outputs More Reliably
See how contract manufacturer Innovize improved organizational performance by participating in VIP.
Get involved with the Voluntary Improvement Program
ELIGIBILITY
- Part of lifecycle for medical devices distributed in the US (Class I, II, III)
- This can be any facility which “designs, manufactures, fabricates, assembles, or processes a finished device.”
- Can include, but is not limited to, “those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.”
- Companies should have all of the following:
- Prior compliance history or compliance profile (i.e. US FDA inspection or MDSAP audit)
- Site registration with US FDA
- Device listing with US FDA
- Facilities must not be under Official Action Indicated (OAI) status or subject to a judicial action. Voluntary Action Indicated (VAI) is acceptable.
- Companies with OAI can become eligible when they have provided the FDA with confirmation that appropriate corrective action has been implemented, and those actions have been verified by the FDA during a follow up inspection.
- Companies may want to seek additional eligibility information if they are a new manufacturer, start-up company, without a compliance profile, or not marketing products in the U.S.
For further guidance view the FDA guidance document “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.”
APPRAISAL
An experienced appraisal team will evaluate your organization’s capabilities through conversations with individual contributors, systems demonstrations, site tours, etc. This evidence is then evaluated against a proven set of best practices, the CMMI model, and the results allow the organization to easily identify areas of strength and opportunities for improvement. You’ll be empowered to prioritize opportunities that align with your business objectives, while quarterly check points provide progress tracking and guidance on improvement projects.
VIP ENGAGEMENT
As a VIP participant, you can take advantage of networking and learning opportunities to shape the future of the program. Our Working Groups, mentorship, monthly participant calls and more create a vibrant community to assist in your overall progress.
Enroll today
Start your path toward continuous improvement today. The recently released FDA Final Guidance enables continuing quality improvements while lessening regulatory burdens through the Voluntary Improvement Program—making now the perfect time to explore how you can boost your organizations’ capabilities.
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Begin the enrollment process today to see how you can boost your organizations manufacturing capabilities to deliver treatments to patients faster and at a higher level of quality.
MDDAP Appraisal - Interest