Diabetes Management Product Expertise
Aptiv Solutions has managed more than 50 projects for diabetes management products and medical devices with related downstream indications. Clients turn to us to meet complex FDA and international regulatory requirements and conduct clinical studies for a range of diabetes management products and related devices. Our experience includes the following:
- Insulin dose calculation systems and software – FDA regulatory strategy and pre-IDE activities
- Neuropathy detection and monitoring devices and systems – FDA regulatory strategy, 510(k) preparation and submission
- Non invasive continuous glucose monitoring systems – Regulatory strategy, pre-IDE support, general regulatory consulting
- Wearable, disposable insulin delivery system - Regulatory strategy, FDA pre IDE support, labeling review, software review, 510(k) preparation and submission
- Intravenous blood glucose systems – Multi-center, US based study including initiation activities, study monitoring and management
- Insulin delivery systems – Manufacturing process validation
- Insulin infuser – Regulatory strategy, clinical trial support and implementation
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 us for advice. With our 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. Aptiv Solutions 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.
