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See 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:

Get involved with the Voluntary Improvement Program

ELIGIBILITY

  1. 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.”
  2. 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
  3. 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.
  4. 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.

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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.

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Additional resources available

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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

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