Gilk Radiology Consultants, LLC (GRC) provides extensive services to manufacturers and vendors of equipment for the MRI environment. With extensive experience with all three aspects of the triangle of standards, regulation, and end-users, GRC can help those seeking to bring new or improved products to the market. Below are several of the services we offer to industry:
Product Development Consultation
- GRC can provide information on the development, regulatory approval, and marketing of products developed for the MRI environment. This includes clinical / FDA-regulated devices, ancillary patient care or support products, as well as products for MRI suite construction and fit-out.
Testing / Labeling / Regulatory Consultation
- Poorly executed product testing and labeling may be worse for a company than no MRI testing and labeling as it can dramatically increase customer service requirements for patients and MRI providers seeking safety information. Having an informed and trusted guide help your company avoid the pitfalls of this process can pay long-term dividends.
Expert Regulatory Code / Standard Interpretations
- New products often don’t fit squarely within existing licensure, regulatory, or accreditation regimes. In many case GRC can provide expert review of codes and standards, including interpretive opinion statements, which can be used for direct client marketing or as resources for regulators or standards-writing officials.
MRI Safety Market Outreach
- Particularly for companies without much existing visibility in the MRI safety community, marketing or educational campaigns can provide significant ‘brand building’ awareness for companies and specific products. This can take the form of educational presentations or marketing initiatives.
GRC industry services are highly customizable and tailored to individual project needs. If you have project needs that are different from (or a combination of) the above, please reach out to us via the CONTACT page.
To return to the page with all three groups of services, please click HERE.