AlvaMed subject matter experts will help you define the regulatory pathway to bring your product to market in the most efficient manner based on the claims being made. Often, this pathway requires clinical data to ensure a successful submission. With considerable experience and knowledge of the IDE process, AlvaMed provides expert support for your products to ensure an efficient submission and review process to kick start your clinical evaluation.
Benchmark against other devices with similar intended uses to help define requirements.
Create a plan to identify required IDE elements including testing and investigational plan requirements.
A Pre-Submission may help clarify requirements and reduce time to IDE approval.
Use your team to draft IDE sections and populate with required content and testing.
Compile the IDE and submit via the FDA CCP portal.
AlvaMed effectively conducted the IDE study, performed study data cleaning, closure, issued the final study report after meeting the client’s enrollment needs, and received De Novo clearance for the client’s device based on final IDE study report data.
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
No. However it is recommended to ensure the proposed testing and clinical trial design will support an IDE approval.
Reference the FDA website here:
https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application
FDA can approve, conditionally approve or disapprove the application.
During his 40 plus career in medical devices, Eric has filed numerous successful IDE submissions in orthopedics, gastroenterology, metabolic disease and neurosurgical therapeutic areas.
Schedule a meeting with Eric to learn how to create a successful submission and guide FDA interactions leading to study approval.
