Jeff Cyr
We want to acknowledge the exceptional regulatory support provided by AlvaMed, particularly in our 510(k) submission process. AlvaMed’s expert guidance, meticulous attention to detail, and unwavering commitment to compliance were pivotal in securing the successful clearance of our medical device. Their knowledge and dedication streamlined what could have been a daunting process, and we are […]
510(k) Clearance
The labeling update was accepted and the device was cleared. The submission was difficult due to the FDA’s test data expectations and the limited time remaining in the review window. The labeling update suggested by the team at AlvaMed successfully brought the client through the review process to market clearance.
President
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
FDA Registration Case Study
AlvaMed completed the registration for the company and coached the company president in the FDA registration process.
