NAMSA has extensive experience with diagnostic, therapeutic and monitoring devices for diabetes. Our experience includes gastric rings, bands, balloons and nerve stimulation for weight loss and potential treatment for Type 2 Diabetes Mellitus (T2DM), as well as blood glucose.
In addition, NAMSA’s highly skilled and experienced regulatory and quality systems consultants have written successful submissions and managed Quality System development and implementation, gap analysis and audits for many companies that market devices for diabetes detection, treatment and care.
Some of the areas where NAMSA has experience with Diabetic devices:
- Blood Glucose Monitors (BGMs): noninvasive monitors, analyzers, and meters; continuous blood glucose monitors; insulin pumps
- HbA1c systems: analyzers and single-unit testing devices
- CLIA Waiver for diagnostic and monitoring devices related to diabetes
- Gastric rings, bands, intragastric balloons and endoscopic surgery for obesity and effect on T2DM
- Nerve stimulation for obesity and effect on T2DM
- Human factors studies – insulin injector pens and other devices
- Tissue engineered devices for treatment of diabetic ulcers
- Islet cell transplants