The Center for Medical Innovation is at the spear tip of medical innovation. The Regulatory Consulting Center’s mission is to be at the tip of that spear by consulting, guiding, and enabling small start-ups and their innovations to fruition.
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.
Who We Are
AN EXPERIENCED AND FOCUSED TEAM OF FACULTY AND STUDENTS
Spencer W. Walker, MSc
Spencer Walker was educated as a Medical Device Development specialist (MSc) at Cranfield University (England/ UK) and has over 16 years of experience in the medical industry, including 10 years as a Regulatory Affairs and Quality Executive and Consultant/Advisor in the area of Medical Device Regulatory/ Quality Compliance. He joined the University's Center for Medical Innovation in 2015 as the Director of Regulatory Affairs, where he currently teaches and consults for new university/ industry based medical device start-ups.
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/Approval: Before 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.