Devices
CTI has significant experience in device and in vitro diagnostic (IVD) development across multiple therapeutic areas.
We have also worked on multiple programs involving combinations of drug /device and cell and gene therapy/device products.
The CTI team has expertise in regulatory submissions including 510(K)s, investigational device exemptions (IDEs), and Premarket Approval Applications (PMAs). We have provided regulatory strategy consulting, clinical trial design and execution, as well as Clinical Evaluation Report (CER) development for our sponsors with device programs. With a full suite of service offerings, including Health Outcomes and Economics, we are often a first choice partner for sponsors with device development support needs.
We offer our sponsors: A history of working in complex and critically ill patient populations
- A team of experienced regulatory experts with knowledge of device development requirements around the world
- Comprehensive service offerings to support programs from concept to commercialization
- Experience with first-in-human, first-in-class, and first-in-patient products
- An employee turnover rate less than half of the reported industry average, resulting in team continuity
- Executive management involvement on every project
- A proven track record of success with more than 100 drug and device approvals
Some of our adult and pediatric experience includes work in:
- Cardiopulmonary
- Endocrinology
- Gastroenterology
- Hematology
- Hepatology
- Neurology
- Nephrology
- Ophthalmology
- Regenerative Medicine
- Transplantation