NAMSA has extensive experience with Class II and Class III gastrointestinal and bariatric devices. Our experience includes gastric rings, bands, balloons and nerve stimulation for weight loss as well as esophageal, gastric biliary and hepatic implants.
In addition, NAMSA’s highly skilled and experienced contract research organization (CRO) regulatory and quality systems consultants have written successful submissions and managed Quality System development, gap analysis and audits for many gastroenterology and urology device companies.
Some areas where NAMSA has experience with Gastrointestinal:
- Implantables to treat GERD
- Biliary stents and hepatic shunts
- Esophageal stents (valved and open)
- Anastomoses devices
- Nerve stimulation for fecal incontinence
- Magnetic sphincter augmentation
- Gastric IVD studies Bariatrics:
- Gastric rings, bands and
- balloons
- Transoral gastroplasty
- Intragastric balloons
- Neurostimulation for weight loss
- Oral appliance for weight loss
- Urostomy valve and pouches
- Aortic aneurysm endografts
- Colostomy products
- Incontinence devices
- Stone management devices