Together, we can help you overcome the unique challenges medical device development presents. As your partner, we can guide you through the ever-changing landscape of regulatory measures, new technologies, and healthcare economics.
We bring the disciplined approach that characterizes successful product development paths, thoughtful regulatory, economic and development strategies, and a meticulous approach to clinical trial execution.
From device classification through to market surveillance on your approved product, our experts work to mitigate risk by navigating applicable regional or global regulations.
We look forward to talking with you, learning more about your specific goals and determining how we can help you.
Sample of Emmes’ Medical Device Experience
- Laser systems for glaucoma
- Minimally invasive glaucoma shunts (MIGS)
- Influenza vaccine/device combination
- Advanced macular degeneration monitoring device
- Diabetic retinopathy AI software
- Reagents for ex-vivo T-cell depletion for GVHD
- Drug coated balloon PTA catheter for treatment of dysfunctional native and synthetic AV fistulae
- Systems for treatment of symptomatic drug-refractory paroxysmal atrial fibrillation
- Systems in patients with central sleep apnea
- Tempered infusions for induction and maintenance of normothermia in refractory febrile patients
- Catheter ablation vs. standard treatment for left ventricular dysfunction and atrial fibrillation