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Diabetes Management Product Expertise

MDCI works with diabetes management product manufacturers to meet clinical, compliance and regulatory requirements to bring the product to market, including:

• Insulin delivery devices - regulatory strategy, pre-IDE, clinical study design, IDE, software documentation review, development of nonclinical testing program, 510(k) premarket notification preparation
• Insulin administration sets and reservoirs - development of nonclinical testing program, 510(k) premarket notification preparation
• Blood glucose monitors - regulatory strategy, pre-IDE, clinical study design, IDE, software documentation review, development of nonclinical testing program, 510(k) premarket notification preparation
• Software products used for blood glucose information management- software documentation review, development of nonclinical testing program, 510(k) premarket notification preparation

Diabetes Management Product Case Study

An established manufacturer of diabetes management products for treatment of Type I diabetes sought to commercialize of a number of new devices and modifications to their currently marketed devices, which incorporated novel technological advancements and enhancements designed to improve the ease of use. The company was concerned about the regulatory implications of these changes and turned to MDCI for advice. With MDCI’s support and guidance the client was able to gain a clearer understanding FDA’s growing concerns regarding the complexity of these devices and the ability of the target user population to operate these devices effectively in a home-based setting. MDCI was also able to ensure that company’s software documentation was adequate to meet FDA requirements for major level of concern software.

Contact us today to learn more about our diabetes management product expertise.