CMMI Institute

Program Requirements




 
  1. Enroll

    Confirm that your organization meets the eligibility requirements and apply for the program.

    Learn More
  2. Participate

    Complete your Medical Device Discovery Appraisal and partake in annual checkpoint.

    Learn More
  3. Receive Regulatory Modifications

    Modified regulatory engagement begins upon signing the SOW for your appraisal and more benefits follow.

    Learn More




Enrollment Requirements

  • 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 proļ¬le
      (for example: US FDA inspection or MDSAP audit)
      For more information, please request a follow-up below.
    • 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,
    • A start-up company,
    • Without a compliance profile,
    • Not marketing products in the U.S.

Participation Requirements

  1. Annual program fee to be paid once you are accepted into the pilot program.

  2. Participation in a Medical Device Discovery Appraisal within the 90-day target and payment of the associated costs.

  3. Check points at defined frequencies to confirm progress and improvement from initial appraisal results.

  4. Sustained favorable compliance profile/history as defined in the enrollment requirements.

Regulatory Modifications

  • Upon signing the Discovery Appraisal SOW, your facility will be removed from the FDA's routine inspection list.

  • Upon completion of a Discovery Appraisal, your manufactured medical devices will be eligible for:

    • Streamlined 30-Day Change Notices, bundling multiple products and changes, with accelerated approval.
    • Streamlined site change submission with accelerated approval.
    • Streamlined PMA submission & waived pre-approval inspection.

Training

Members of your organization can participate in the appraisal as an Internal Appraisal Team Member (ATM). In the MDDAP Intro Course, your team will learn the CMMI V2.0 model used in the program, understand model adoption in the medical device space to achieve measurable business objectives, and prepare to evaluate your organization’s capabilities during the appraisal.

Contact us using the form below to learn about our training options.

Request a Follow-Up

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.

All fields are required.