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ADVISING, FORECASTING, PLANNING

Regulatory & Quality Services

  • Plan strategically from design to market
  • Identify the regulatory requirements for medical and IVD devices and provide advice and services for compliance
  • Prepare and assist clients in regulatory submissions, manufacturing compliance, quality system implementation, and other regulatory requirements for most Class I & Class II devices.

How We Work

TALENT DIRECTED TO YOUR PRODUCT

The CMI Regulatory Consulting Center focuses the expertise of its faculty, associates and student interns on regulatory challenges that face your medical product(s). We provide advice and services to student and faculty inventors, start-up companies with interesting products, or others who just need a little extra regulatory help.

To start, we will sit with you for an hour without any charge. If you decide we can help you, we can set up a project plan with you. This is particularly important if you are applying for a grant and need letters or text regarding our contributions. We will then identify experts and students according to your needs.

What We Do

We provide advice and services to students, faculty, and industry with interesting products, and anyone else who might need a little extra regulatory help. We do this by:

  • Quality System (QS) Implementation (21 CFR 820 and ISO 13485): Required for manufacturers to have for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution.
  • Conception: The scientific principles upon which a device is based are fundamental to its safety and performance. The more complex the device, the higher the risk of the user error. Soundness of concept and adequacy of design, construction and testing require the scrutiny of scientific experts to ensure that design parameters and performance characteristics do not impose unwarranted risks.
  • Design Control: The quality system regulation (21 CFR 820) includes design controls which must be complied with during the design and development of the device. Design control is a systematic way to follow product design from user requirements to final product.
  • FDA Filing/ApprovalBefore a medical device can be marketed in the USA a marketing application must be submitted to the FDA and clearance obtained.
    • Exemptions: Most Class I devices and a few Class II devices are exempt from the requirement for submission of a marketing application. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.
    • 510(k): Most Class II devices require Premarket Notification 510(k). A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective, and substantially equivalent, to a legally marketed device. If your device requires the submission of a Premarket Notification 510(k) you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing, you to do so.

 

Flexible Payment Options

Payment for our consultation and filing services can set up in multiple ways, including direct fee-for-service(s) and long(er)-term contracts billed monthly. Pricing discounts may apply to University of Utah students, staff, and affiliated faculty. For more information regarding pricing, please contact us directly.